Identity
- Model / Reference
- iPKS EUDAMED12974-00-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08836913268082 EUDAMED
- Basic UDI-DI
- 088369112974FC EUDAMED
- EMDN Code
- Y061209 KNEE 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
12974-00-01 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 | 088369112974FC | 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 1104cf3a-d965-4de2-b1a4-786f566bc1e8 61 fields · synced Jul 8, 2026