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Wrist Splint With Elastic Strap
EUDAMEDClass I (EU MDR)
Ref 2288-BG-M-1Ref RH301-BK-F-1Ref 2288-BG-S-1Ref 1082-BG-L-1Ref 1082-BG-XL-1Ref 2288-BG-L-1
Identity
- Trade Name
- Wrist Splint With Elastic Strap EUDAMEDWrist Splint EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 2288-BG-M-1 EUDAMEDRH301-BK-F-1 EUDAMED2288-BG-S-1 EUDAMED1082-BG-L-1 EUDAMED1082-BG-XL-1 EUDAMED2288-BG-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863698274 EUDAMED04713375500445 EUDAMED04719863698267 EUDAMED04719863690797 EUDAMED04719863690803 EUDAMED04719863698281 EUDAMED
- Basic UDI-DI
- 471986369CL103DH EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Wrist Splint With Elastic Strap by OPPO Medical Corp. — 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 | 471986369CL103DH | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (6)
- EUDAMED 8087c46f-7822-458a-b428-f6dfd7b5245a 61 fields · synced Oct 6, 2026
- EUDAMED 986314a5-e183-45c6-bfef-a18ba658dee2 61 fields · synced May 17, 2026
- EUDAMED 09072196-4aa9-4526-94af-7561a7ac78be 61 fields · synced May 17, 2026
- EUDAMED b6489732-761c-4cb5-b617-96870f615077 61 fields · synced May 17, 2026
- EUDAMED 330e3cdd-c028-496d-9928-70c4448ae950 61 fields · synced May 18, 2026
- EUDAMED 48186cd8-7149-4412-ac0e-54afc0c22a14 61 fields · synced May 18, 2026