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Temblak Kończyny Górnej
EUDAMEDClass I (EU MDR)
Ref O-1500/XLModel O-1500Ref O-1500/MRef O-1500/SRef O-1500/L
Identity
- Trade Name
- TEMBLAK KOŃCZYNY GÓRNEJ EUDAMED
- Device Name
- Temblak kończyny górnej EUDAMED
- Model / Reference
- O-1500 EUDAMEDO-1500/XL EUDAMEDO-1500/M EUDAMEDO-1500/S EUDAMEDO-1500/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903940706894 EUDAMED05903940706870 EUDAMED05903940706887 EUDAMED05903940706863 EUDAMED
- Basic UDI-DI
- 59039407O1500DM EUDAMED
- Direct Marketing DI
- 05903940706894 EUDAMED05903940706870 EUDAMED05903940706887 EUDAMED05903940706863 EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Temblak Kończyny Górnej by REHA FUND Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 59039407O1500DM | Class I | Active |
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Manufacturer
- Manufacturer
- REHA FUND Sp. z o.o.
- EUDAMED SRN
- PL-MF-000047481
Sources (4)
- EUDAMED 60e87dd1-68c4-429b-a6e4-c6b707c952c0 61 fields · synced Oct 5, 2026
- EUDAMED 1b46a02f-f5a7-4884-9500-3ad02e260125 61 fields · synced May 17, 2026
- EUDAMED c69a9093-ce71-4f90-95f8-c9ea60221fac 61 fields · synced May 17, 2026
- EUDAMED dfdc2256-b8f8-4ac6-8a8b-6f737c2079a3 61 fields · synced May 17, 2026