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Orthosis Splints
EUDAMEDClass I (EU MDR)
Ref 81293299Model OrthopedicsRef 81293307Ref 81293448
Identity
- Trade Name
- ORTHOSIS SPLINTS EUDAMED
- Device Name
- Upper Extremity EUDAMED
- Model / Reference
- Orthopedics EUDAMED81293299 EUDAMED81293307 EUDAMED81293448 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914037638 EUDAMED00885914037645 EUDAMED00885914037713 EUDAMED
- Basic UDI-DI
- 08859140000000000000009L4 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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
Orthosis Splints by Performance Health Supply, LLC — 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 | 08859140000000000000009L4 | Class I | Active |
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Manufacturer
- Manufacturer
- Performance Health Supply, LLC
- EUDAMED SRN
- US-MF-000003318
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED d6f39805-9e97-46fd-a9b0-a14bae11fd5a 61 fields · synced Jul 28, 2026
- EUDAMED bab19c04-45b2-48b0-8d2c-1b481d13f3d1 61 fields · synced May 18, 2026
- EUDAMED 8794740a-12c8-4b9a-91d0-b3b327073462 61 fields · synced May 19, 2026