Manufacturer

Remed

South Korea, UkraineLegal entities : PRIVATE ENTERPRISE "REMED", REMED Co.,Ltd.

Markets : Germany · Poland · Romania · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 12 · class II · latest in 2022 · see on the FDA website

EU representative : GSI-CERT German Scientific Institute for Quality, Testing and Certification GmbH (Germany)

Website info@remed.ua

13 categories, 21 models including 21 on the market, 2 countries

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

Category	EMDN code	Registered models	Class	Contact
Cervical spine orthoses	Y060312	Kołnierz ortopedyczny półsztywny typu Florida (Ortopedio by Synoptis) R11033 refs Kołnierz ortopedyczny typu Schantza (Ortopedio by Synoptis) R11013 refs Kołnierz ortopedyczny typu Shantza dla dziecka (Ortopedio by Synoptis) R1103 KIDS3 refs	I MDR	EUDAMED record Report an error
Hand orthoses	Y060606	Orteza kończyny górnej Temblak (Ortopedio by Synoptis) R91033 refs Orteza kończyny górnej Temblak dla dzieci (Ortopedio by Synoptis) R9103 KIDS3 refs Orteza palcowa ręki RS1 (Ortopedio by Synoptis) R8310	I MDR	EUDAMED record Report an error
Muscle stimulators	Z120622	COMPACT-II, ExMS-A, PERFECT, SALUS-TALENT-A, SALUS-TALENT-A8, SALUS-TALENT-Pro, SALUS-TALENT-Pro-Aes, UI CUBE, UI CUBE(H)3 refs ZTone	IIa MDR	EUDAMED record Report an error
Shoulder-elbow orthoses	Y060624	Orteza na ramię i bark typu Dessault (Ortopedio by Synoptis) R92013 refs Orteza na ramię i bark typu Dessault RS1 (Ortopedio by Synoptis) R91083 refs	I MDR	EUDAMED record Report an error
Thoracolumbosacral spine orthoses	Y060309	Pas obojczykowy-Pajączek (Ortopedio by Synoptis) R2303 Wysoka orteza lędźwiowo-krzyżowo-piersiowa RS1 (Ortopedio by Synoptis) R23013 refs	I MDR	EUDAMED record Report an error
Wrist (forearm) orthoses	Y060609	Orteza nadgarstka długa (Ortopedio by Synoptis) R83013 refs Orteza nadgarstka krótka (Ortopedio by Synoptis) R8301S black3 refs	I MDR	EUDAMED record Report an error
Elbow orthoses	Y060615	Orteza łokcia tenisisty RS1 (Ortopedio by Synoptis) R9206	I MDR	EUDAMED record Report an error
Lumbosacral spine orthoses	Y060308	Pas lędźwiowo - krzyżowy z usztywnieniem (Ortopedio by Synoptis) R33023 refs	I MDR	EUDAMED record Report an error
Magnetic stimulators	Z12101105	BrainStim, TAMAS, ALTMS3 refs	IIb MDR	EUDAMED record Report an error
Patient positioning medical cushions	V080302	Poduszka ortopedyczna (Ortopedio by Synoptis) PMP-6053 refs	I MDR	EUDAMED record Report an error
Shock wave therapy equipment	Z12139001	FSWT-A SALUS-ESWT-EXPERT, SLAUS-FSWT, RSWT-A3 refs	IIa MDR	EUDAMED record Report an error
Various physiotherapy and rehabilitation instruments - other	Z12069099	Smart TMT	IIa MDR	EUDAMED record Report an error
Wrist-hand-fingers orthoses	Y060613	Orteza nadgarstka z ujęciem kciuka (Ortopedio by Synoptis) R83043 refs	I MDR	EUDAMED record Report an error

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