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Orteza kończyny dolnej
EUDAMEDClass I (EU MDR)
Ref AM-KDS-AM/2R L/MModel AM-KDS-AM/2R
Identity
- Trade Name
- Orteza kończyny dolnej EUDAMED
- Model / Reference
- AM-KDS-AM/2R EUDAMEDAM-KDS-AM/2R L/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05900949720791 EUDAMED
- Basic UDI-DI
- 59009497AM-KDS-AM/2RN3 EUDAMED
- Direct Marketing DI
- 05900949720791 EUDAMED
- EMDN Code
- Y06121202 ENERGY RETURN ORTHOSES FOR KNEE-ANKLE-FOOT 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
Orteza kończyny dolnej by REH4MAT Spółka z ograniczoną odpowiedzialnością — 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 | 59009497AM-KDS-AM/2RN3 | Class I | Active |
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Manufacturer
- Manufacturer
- REH4MAT Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000009271
Sources (1)
- EUDAMED e47289cd-5074-4ff5-99df-e833aa8933f8 61 fields · synced Oct 7, 2026