Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsInfusion instruments

Infusion instruments - consumables

EMDN code Z12030385

10 manufacturers, 210 models including 207 on the market, 6 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 10

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
EMED Technologies FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	EMED Sub-Q Infusion Set SUB-109-G2493/42 OPTFLOW OPT12404U93/42 OPTFLOW OPT12406U93/42 OPTFLOW OPT12409U93/42 OPTFLOW OPT12412U93/42 127 others OPTFLOW OPT12414U93/42 OPTFlow OPT1260493/42 OPTFLOW OPT1260693/42 OPTFLOW OPT1260993/42 OPTFlow OPT12609-4693/42 OPTFlow OPT12609U93/42 OPTFlow OPT1261293/42 OPTFlow OPT12612U93/42 OPTFlow OPT1261493/42 OPTFlow OPT12614U93/42 OPTFlow OPT1290993/42 OPTFlow OPT22404U93/42 OPTFlow OPT22406U93/42 OPTFlow OPT22412U93/42 OPTFlow OPT22414U93/42 OPTFlow OPT2260493/42 OPTFlow OPT2260693/42 OPTFlow OPT2260993/42 OPTFlow OPT22609U93/42 OPTFlow OPT2261293/42 OPTFlow OPT22612U93/42 OPTFlow OPT2261493/42 OPTFlow OPT22614U93/42 OPTFlow OPT32406U93/42 OPTFlow OPT32409U93/42 OPTFlow OPT32412U93/42 OPTFlow OPT32414U93/42 OPTFlow OPT3260693/42 OPTFlow OPT3260993/42 OPTFlow OPT32609U93/42 OPTFlow OPT3261293/42 OPTFlow OPT32612U93/42 OPTFlow OPT3261493/42 OPTFlow OPT32614U93/42 OPTFlow OPT42406U93/42 OPTFlow OPT42409U93/42 OPTFlow OPT42412U93/42 OPTFlow OPT42414U93/42 OPTFlow OPT4260693/42 OPTFlow OPT4260993/42 OPTFlow OPT42609U93/42 OPTFlow OPT4261293/42 OPTFlow OPT42612U93/42 OPTFlow OPT4261493/42 OPTFlow OPT42614U93/42 OPTFlow OPT52409U93/42 OPTFlow OPT52412U93/42 OPTFlow OPT5260693/42 OPTFlow OPT5260993/42 OPTFlow OPT52609U93/42 OPTFlow OPT5261293/42 OPTFlow OPT52612U93/42 OPTFlow OPT62409U93/42 OPTFlow OPT62412U93/42 OPTFlow OPT6260993/42 OPTFlow OPT62609U93/42 OPTFlow OPT6261293/42 OPTFlow OPT62612U93/42 OPTFlow OPT62614U93/42 OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 46cm Tubing OPT12609—46Q1093/42 SAF-Q-106-G2793/42 SAF-Q-106-S93/42 SAF-Q-106-SNF93/42 SAF-Q-109-G2493/42 SAF-Q-109-G24-1293/42 SAF-Q-109-G2793/42 SAF-Q-109-G27-7093/42 SAF-Q-109-G27-SNF93/42 SAF-Q-109-G29-7093/42 SAF-Q-112-G24-1293/42 SAF-Q-112-G24-7093/42 SAF-Q-112-G2793/42 SAF-Q-206-G24-7093/42 SAF-Q-206-G2793/42 SAF-Q-209-G24-7093/42 SAF-Q-209-G2793/42 SAF-Q-212-G24-7093/42 SAF-Q-212-G2793/42 SAF-Q-306-G2793/42 SAF-Q-309-G2493/42 SAF-Q-309-G2793/42 SAF-Q-312-G24-7093/42 SAF-Q-312-G2793/42 SAF-Q-406-G2793/42 SAF-Q-409-G24-7093/42 SAF-Q-409-G2793/42 SAF-Q-412-G24-7093/42 SAF-Q-412-G2793/42 SAF-Q-509-G2793/42 SAF-Q-609-G2793/42 SUB-104-G2793/42 SUB-106-G2793/42 SUB-106-G27-7093/42 SUB-106-S93/42 SUB-106-SNF93/42 SUB-109-G24-1293/42 SUB-109-G2793/42 SUB-109-G27-7093/42 SUB-112-G2493/42 SUB-112-G2793/42 SUB-112-G27-7093/42 SUB-204-G2793/42 SUB-209-G2493/42 SUB-212-G2493/42 SUB-212-G2793/42 SUB-25093/42 SUB-26093/42 SUB-27093/42 SUB-309-G2493/42 SUB-31093/42 SUB-312-G2493/42 SUB-312-G2793/42 SUB-32093/42 SUB-40093/42 SUB-409-G2493/42 SUB-41093/42 SUB-410-NS93/42 SUB-412-G2493/42 SUB-412-G2793/42 SUB-414-G2793/42 SUB-47093/42 SUB-50693/42 SUB-50993/42 SUB-512-G2493/42 SUB-60693/42 SUB-60993/42 SUB-612-G2493/42	IIa 93/42	Website customerservice@emedtc.com EUDAMED record Report an error
Sooil FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	DANA 3cc Syringe93/42 ER064593/42 ER067093/42 ER069093/42 ER074593/42 49 others ER077093/42 ER079093/42 ER117093/42 ER119093/42 SR10293/42 SR102 10box93/42 SR11293/42 SR112 10box93/42 SU00193/42 SU001-10box93/42 SU00293/42 SU002-10box93/42 SU00393/42 SU003-10box93/42 SU10193/42 SU101-10box93/42 SU10293/42 SU102-100box93/42 SU102-10box93/42 SU20193/42 SU201-10box93/42 SU20293/42 SU202-10box93/42 SU20393/42 SU203-10box93/42 SU20493/42 SU204-10box93/42 SU30193/42 SU302 10box93/42 SU30393/42 SU303 10box93/42 SU31193/42 SU31293/42 SU312 10box93/42 SU31393/42 SU313 10box2 refs93/42 SU31493/42 SU314 10box93/42 SU31593/42 SU315 10box93/42 SU31693/42 SU316 10box93/42 SU31793/42 SU317 10box93/42 SU31893/42 SU318 10box93/42 SU31993/42 SU319 10box93/42 Z12030385 SU301 10box93/42	IIa 93/42	Website EUDAMED record Report an error
Surgical International	Netherlands	Fluido® Compact Standard Set 67200093/42 Fluido® Irrigation Catheter Connector 68091293/42 Fluido® Irrigation Female Connector 68091093/42 Fluido® Irrigation Funnel Connector 68091393/42 Fluido® Irrigation Male Connector 68091193/42 8 others Fluido® Irrigation URO Male Connection 68080593/42 Fluido® Trauma Plus Set 67170093/42 Fluido®Compact Standard Set with drip chamber 67210093/42 Fluido®Irrigation URO Patient Line 680801-B93/42 Fluido®Irrigation URO Spike Set 680803-B93/42 Fluido® Standard Set 67120093/42 (no longer marketed) Fluido® Trauma Set 67150093/42 (no longer marketed) Fluido®Irrigation URO Set 670800-B93/42 (no longer marketed)	IIa 93/42	Website raqa.ptm@tsc-life.com EUDAMED record Report an error
Zevex FDA EU representative : UAB Moog Vilnius (Lithuania)	United States	Non-DEHP Admin Set with Non-Vent Spike and .2μ Filter, ASV 380-41732 refs Non-DEHP Admin Set with Non-Vented Spike and .2μ Filter 380-41283 refs Non-DEHP Admin Set, Vented .2 μ Filter, Vented Vial Spike 380-41143 refs Non-DEHP Epidural, Yellow Striped Tubing Admin Set, Non-Vent Spike Vented .2μ Filter 380-41443 refs Non-DEHP Epidural, Yellow Striped Tubing Admin Set, Non-Vent Spike, Vented 0.2 μm Filter, ASV, NRFit 380-41923 refs	IIa MDR	EUDAMED record Report an error
Aptmed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	OmniPump™ 166S-IP-1	IIa MDR	Website info@aptmed.com EUDAMED record Report an error
Bisinger Handels	Germany	PCA Einweg-Pumpentasche 100-ml2 refs	I MDR	Website EUDAMED record Report an error
Eitan Medical FDA EU representative : MedNet EC-REP IIb GmbH (Germany)	Israel	AP101 AVOSET; SAPPHIRE3 refs	IIa MDR	support@eitanmedical.com EUDAMED record Report an error
Lenus Infusionstechnik	Germany	LENUS Infusion Set Neuraxial PCA - Bag 150ml TPN Spike3 refs	IIa MDR	Website info@lenus-infusionstechnik.de EUDAMED record Report an error
Shandong Wuzhou Medical Equipment EU representative : Lotus NL B.V. (Netherlands)	China	W-IS-GA W-IS-GB W-IS-GC W-IS-GD	IIa MDR	EUDAMED record Report an error
Shenzhen Med-link Electronics Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pressure Infusion Bag Y000P053 refs	I MDR	Website sales@med-linket.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 19

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Tandem Diabetes Care, Inc. Present in Europe in other categories	United States	t:slim Cartridge, t:lock, 10 Pack t:slim X2 Insulin Pump t:slim Cartridge 2 Pack t:slim Insulin Pump, Demonstration t:slim Cartridge 10 Pack t:flex Cartridge, t:lock, 10 Pack	K162080 (2016)
Modular Medical, Inc.	United States	MODD1 Pump PIVOT Insulin Pump Starter Kit PIVOT Insulin Pump Replacement PIVOT Supply Kit (1pk) MMI App for iOS MODD1 Starter Kit	K262153 (2026)
Insulet Corporation Present in Europe in other categories	United States	Omnipod Omnipod DASH Pod Omnipod Go Insulin Delivery Device 30U/day Omnipod DASH PDM Omnipod Go Insulin Delivery Device 35U/day Omnipod Go Insulin Delivery Device 10U/day POD	K223372 (2023)
CEQUR CORPORATION	United States	CeQur Simplicity	registered
MANNKIND CORPORATION	United States	V-Go Disposable Insulin Delivery	registered
Medtronic Minimed Present in Europe in other categories	United States	Paradigm® REAL-Time Revel™ Extended Reservoir Paradigm®	K241622 (2024)
ADVANCE TECHNOLOGY LTD	China	–	registered
Flextronics International USA, Inc.	United States	–	registered
Fresenius Kabi AG Present in Europe in other categories	Germany	–	registered
ICU MEDICAL, INC. Present in Europe in other categories	United States	–	registered
INTRICON CORPORATION	United States	–	registered
Mainline Medical Dental Supply	Canada	–	registered
Medtronic, Inc. Present in Europe in other categories	United States	–	registered
PROVIDENCE ENTERPRISE LTD.	Hong Kong SAR China	–	registered
Phillips-Medisize A/S Present in Europe in other categories	United States	–	registered
Roche Diagnostics Operations Inc.	United States	–	registered
Sanmina Corporation	United States	–	registered
YPSOMED AG Present in Europe in other categories	Switzerland	–	registered
Zollner Electronics Costa Rica Limitada	Costa Rica	–	registered

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