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Ankle Activator
EUDAMEDClass I (EU MDR)
Ref 2903-R-GY-L-1Ref 2903-R-GY-M-1Ref 2903-L-GY-S-1Ref 2903-L-GY-M-1Ref 2903-R-GY-S-1Ref 2903-L-GY-XL-1
Identity
- Trade Name
- Ankle Activator EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2903-R-GY-L-1 EUDAMED2903-R-GY-M-1 EUDAMED2903-L-GY-S-1 EUDAMED2903-L-GY-M-1 EUDAMED2903-R-GY-S-1 EUDAMED2903-L-GY-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769156346 EUDAMED04711769156339 EUDAMED04711769156568 EUDAMED04711769156575 EUDAMED04711769156322 EUDAMED04716609639973 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
Ankle Activator 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 (6)
- EUDAMED 29242549-e4b3-4024-96b3-0de12e64322b 61 fields · synced Oct 6, 2026
- EUDAMED 7d2f4e18-177c-45c9-92ef-b53fdee0e986 61 fields · synced May 11, 2026
- EUDAMED 1ea3c958-a700-44e5-a4eb-8303a16e3ad5 61 fields · synced May 17, 2026
- EUDAMED ec4b54bc-f6b2-4ca7-abf2-fc842b172f22 61 fields · synced May 17, 2026
- EUDAMED 97d37d71-e220-4b48-b727-77e25f358abf 61 fields · synced May 18, 2026
- EUDAMED e0445b28-b267-4eed-8998-54e8dab891d1 61 fields · synced May 19, 2026