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Rigid Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 550-L-GY-LRef 550-R-GY-MRef 550-L-GY-SRef 550-L-GY-M
Identity
- Trade Name
- Rigid Wrist Brace EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 550-L-GY-L EUDAMED550-R-GY-M EUDAMED550-L-GY-S EUDAMED550-L-GY-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269510656 EUDAMED00840269510625 EUDAMED00840269510618 EUDAMED00840269510632 EUDAMED
- Basic UDI-DI
- 08402695CL1038G EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Rigid Wrist Brace by La Pointique Int´l Ltd. — 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 | 08402695CL1038G | Class I | Active |
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Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED 0e2ab80f-2731-4d5f-ac72-af0bbc933fea 61 fields · synced Jul 17, 2026
- EUDAMED a47473b1-428b-44cc-8566-1f4bc3812958 61 fields · synced May 17, 2026
- EUDAMED a22749a6-919a-4d59-8a2a-6017c4008c3b 61 fields · synced May 17, 2026
- EUDAMED 1cd73fbb-68bf-4b84-9a70-3be77143bdd8 61 fields · synced May 18, 2026