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Force-in-one Patella Stabilizer
EUDAMEDClass I (EU MDR)
Ref 2921-L-GY-XXXXL-1Ref 2921-L-GY-L-1Ref 2921-L-GY-M-1Ref 2921-R-GY-XXXXL-1Ref 2921-R-GY-XXL-1Ref 2921-L-GY-S-1Ref 2921-R-GY-M-1
Identity
- Trade Name
- Force-in-one Patella Stabilizer EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2921-L-GY-XXXXL-1 EUDAMED2921-L-GY-L-1 EUDAMED2921-L-GY-M-1 EUDAMED2921-R-GY-XXXXL-1 EUDAMED2921-R-GY-XXL-1 EUDAMED2921-L-GY-S-1 EUDAMED2921-R-GY-M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769143957 EUDAMED04711769155882 EUDAMED04711769155875 EUDAMED04711769143933 EUDAMED04711769155806 EUDAMED04711769155868 EUDAMED04711769155776 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - 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
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
Force-in-one Patella Stabilizer 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 | 471986369CL102DF | 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 (7)
- EUDAMED e785f3a1-d867-4586-8ea3-d04ccfeb625b 61 fields · synced Oct 5, 2026
- EUDAMED 2ac858e9-44a3-4f9b-ac51-8c6992dad6ea 61 fields · synced May 17, 2026
- EUDAMED 4cbf68a6-f6b7-43fa-82f9-294c9bb2b681 61 fields · synced May 17, 2026
- EUDAMED bd74d099-049a-41b8-84dc-d2a988b2ac25 61 fields · synced May 18, 2026
- EUDAMED a5a5227d-62e2-438b-a123-5f367495934a 61 fields · synced May 18, 2026
- EUDAMED a79b7bee-ad12-41ad-a07c-f64e38516bc5 61 fields · synced May 18, 2026
- EUDAMED 3d60679e-45f7-4e53-a897-ee06e60566c7 61 fields · synced May 18, 2026