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Universal Thumb Orthosis
EUDAMEDClass I (EU MDR)
Ref 73264-00-01Model 1147Ref 73265-00-01
Identity
- Device Name
- Universal Thumb Orthosis EUDAMED
- Model / Reference
- 1147 EUDAMED73264-00-01 EUDAMED73265-00-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08836913072412 EUDAMED08836913072580 EUDAMED
- Basic UDI-DI
- 088369173264GF EUDAMED088369173265GH EUDAMED
- EMDN Code
- Y060612 WRIST-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
Universal Thumb 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 | 088369173264GF | 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 (2)
- EUDAMED 43c52142-bb54-4eeb-b5f2-b61ed6c368cb 61 fields · synced Jul 22, 2026
- EUDAMED e8df3956-7236-4a57-9ba6-8d9e3ad810fb 61 fields · synced May 18, 2026