Identity
- Device Name
- Platform Hand Orthosis EUDAMED
- Model / Reference
- 1105 EUDAMED73195-00-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08836912043598 EUDAMED
- Basic UDI-DI
- 088369173195GM EUDAMED
- EMDN Code
- Y060606 HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Platform Hand Orthosis by Professional Products, Inc. — 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 | 088369173195GM | Class I | Active |
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Manufacturer
- Manufacturer
- Professional Products, Inc.
- EUDAMED SRN
- US-MF-000019828
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 235b261c-ef32-4d9b-a915-42961fd8945a 61 fields · synced Jul 19, 2026