Non-specific consumables for diagnostic instruments

X-ray films

EMDN code Z1301

16 manufacturers, 37 models including 37 on the market, 8 countries

On the market in Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 16

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
Skydent	Slovakia	DENTIX D2 refs93/42 DENTIX E93/42 DENTIX F93/42 PRIMAX RDX-58 E93/42 SKYDENT D2 refs93/42 2 others SKYDENT E3 refs93/42 SKYDENT F93/42	IIa 93/42	Website EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands)	Japan	DRYPRO MODEL TH3 refs SD-E3 refs SD-P, SD-PM, SD-Q, SD-QM, SD-Q2, SD-QM2 SD-S, SD-SM Plus3 refs TR-S3 refs	I MDR	EUDAMED record Report an error
Agfa FDA	Belgium	CAWO DRY FILM3 refs CP-BU M8 refs93/42 Ortho CP-GU M10 refs93/42	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Colenta	Austria	HighCap XLp DICOM Printer2 refs MEDIPHOT DL - Dry Laser Imaging Film 26x36cm (10"x14") - 150 sheets DLFilm2 refs MEDIPHOT DLM - Dry Laser Mammography Imaging Film 20x25cm (8"x10") - 150 sheets DLMFilm3 refs	I MDR	EUDAMED record Report an error
Tianjin KangMeiTu YunYi Medical Instruments EU representative : MedPath GmbH (Germany)	China	Medical Laser Imaging Film KMT-G-20cm×25cm3 refs Medical printing film KMT-C-11in×14in3 refs Medical Thermal Dry Image Film KMT-F-10in×12in3 refs	I MDR	EUDAMED record Report an error
Duerrdental FDA	Germany	Imaging Plate Size 03 refs VistaScan Image Plate 127x3053 refs	IIa MDR	Website regulatory@duerrdental.com EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany)	Japan	Fuji Medical Dry Imaging Film3 refs FUJI Medical X-ray Film3 refs	I, IIa MDR	EUDAMED record Report an error
Jiangsu Taike Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	TK-410（14×17）in、TK-410（13×17）in、TK-410（11×14）in、TK-410（10×14）in、TK-410（10×12）in、TK-410（8×10）in、TK-410-A3、TK-410-A4、etc3 refs TK-JG-A 14in×17in、TK-JG-A 13in×17in、TK-JG-A 14in×14in、TK-JG-A 11in×14in、TK-JG-A 10in×14in、TK-JG-A 10in×12in、TK-JG-A 8in×10in、TK-JG-A A3、TK-JG-A A4、TK-JG-A 16K、TK-JG-A B5; etc3 refs	I MDR	EUDAMED record Report an error
Smart Health Biotech (Guangxi) EU representative : Lotus NL B.V. (Netherlands)	China	MEDICAL DRY FILM SM-HTO-C3 refs MEDICAL DRY LASER FILM SM-HLJ-C3 refs	I MDR	EUDAMED record Report an error
Wolf X-Ray FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Flow Dental Intraoral X-ray Film 18310E93/42 Flow Dental Intraoral X-ray Film 18635E93/42	IIa 93/42	Website EUDAMED record Report an error
Changshu Pingfang Wheelchair FDA EU representative : R Sight B.V. (Netherlands)	China	ELECTRIC WHEELCHAIR F308, F309, F310, E08P3 refs	I MDR	EUDAMED record Report an error
Codonics FDA EU representative : AR Experts B.V. (Netherlands)	United States	Codonics ChromaVista Paper/WhiteFilm, A-CVP DirectVista Medical Film3 refs	I MDR	Website EUDAMED record Report an error
Dimedi FDA EU representative : AF Pharma Service Europe SL (Spain)	South Korea	ZEROPSP- TYPE13 refs	I MDR	Inquiry@mtgs.co.kr EUDAMED record Report an error
Hangzhou Meiqing Digital Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	R-001，R-002，R-003，R-004，R-005，R-006，R-007，R-008，R-009，R-010	I MDR	EUDAMED record Report an error
Inpixel Medical Technology EU representative : Wellkang Ltd (Northern Ireland)	China	Dental image plate IP003 refs	I MDR	EUDAMED record Report an error
Weifang Hengcai Digital Photo Materials EU representative : SUNGO Europe B.V. (Netherlands)	China	RM-HA1 8x10inch,RM-HA1 10x12inch,RM-HA1 11x14inch,RM-HA1 14x17inch,RM-HL 8x10inch,RM-HL 10x12inch,RM-HL 11x14inch,RM-HL 14x17inch	I MDR	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) 33

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
Carestream Health, Inc. Present in Europe in other categories	United States	DRYVIEW DVB Laser Imaging Film Ultra-speed Medical X-ray Green / MXG Film T-MAT G/RA Film INSIGHT DRYVIEW DVE Laser Imaging Film	registered
Flow X Ray Corporation	United States	PureLife X-Ray Film UnoDent Minimax Bitewing TRX-3 Minimax TRX-S SAFCO D SPEED FILM FILM FSS-54 D CHILD SINGLE FILM BUTTERFLY PACKETS F SPEED	registered
Palodex Group OY Present in Europe in other categories	Finland	Imaging Plates OCCLUSAL 4C KIT SCAN EXAM OCCLUSAL 4C START-UP KIT	registered
HENRY SCHEIN, INC. Present in Europe in other categories	United States	Henry Schein	registered
Air Techniques, Inc. Present in Europe in other categories	United States	Phosphor Storage Plate Phosphor Storage Plate Guide Size 2 Phosphor Storage Plate Guide Size 3 Plate Transfer Box Phosphor Storage Plate Guide Size 4 Phosphor Storage Plate Guide Size 0	registered
TYPENEX MEDICAL LLC Present in Europe in other categories	United States	Rad Control IRRADIATION INDICATOR TAG	registered
BENCO DENTAL SUPPLY CO.	–	VISION XR	registered
DARBY DENTAL SUPPLY, LLC	–	Darby Dental Supply, LLC	registered
SAFCO DENTAL SUPPLY CO.	United States	Safco panoramic film Safco X-Pose intraoral x-ray film Safco duplicating film	registered
Young Innovations, Inc.	United States	The Orthodontic Store	registered
NATIONAL DISTRIBUTION & CONTRACTING, INC.	–	Quala	registered
3D DENTAL DESIGNS AND DEVELOPMENT, LLC	–	Visionary by 3D Dental	registered
Sun Nuclear Corp. Present in Europe in other categories	United States	Precision Cut GafChromic™ Film	registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories	United States	–	registered
Agfa-Gevaert AG	United States	–	registered
Aktina Medical Corporation Present in Europe in other categories	United States	–	registered
BIOSEAL	United States	–	registered
CARESTREAM DENTAL LLC Present in Europe in other categories	United States	–	registered
CBR Enterprise Limited	Hong Kong SAR China	–	registered
DHEF INC. Present in Europe in other categories	Taiwan	–	registered
HPC Ventures, LLC	United States	–	registered
Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda.	Brazil	–	registered
Mainline Medical Dental Supply	Canada	–	registered
ONVET MEDICAL CANADA INC	Canada	–	registered
On Point Medicals GmbH	Austria	–	registered
Ortho Organizers, Inc.	United States	–	registered
PALM MEDICAL INTERNATIONAL BV	Belgium	–	registered
SAMTRADE SUPPLIES INC.	Canada	–	registered
Shanghai Alwings Medical Instrument Co.,Ltd.	China	–	registered
Soher Med Limited	Hong Kong SAR China	–	registered
WHITE MOUNTAIN IMAGING	United States	–	registered
ZAW gGmbH	Germany	–	registered
ZOGEAR Medical Co., Ltd. Present in Europe in other categories	China	–	registered

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