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Ulnar Splints
EUDAMEDClass I (EU MDR)
Ref 81287036Model OrthopedicsRef 81287028Ref 81287044
Identity
- Trade Name
- ULNAR SPLINTS EUDAMED
- Device Name
- Upper Extremity EUDAMED
- Model / Reference
- Orthopedics EUDAMED81287036 EUDAMED81287028 EUDAMED81287044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914035214 EUDAMED00885914035207 EUDAMED00885914035221 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
Ulnar 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 768af3a3-5c2e-463d-98d9-64e33702604b 61 fields · synced Jul 27, 2026
- EUDAMED 08cc8998-5a90-48a0-acfe-6f115d80f221 61 fields · synced May 17, 2026
- EUDAMED 460c9c72-a7a8-45ca-8507-1d1c01931144 61 fields · synced May 19, 2026