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Retractor
EUDAMEDClass I (EU MDR)
Ref 6422-L-1Ref 6422-M-1Ref 6424-M-1Ref 6424-L-1
Identity
- Trade Name
- Retractor EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 6422-L-1 EUDAMED6422-M-1 EUDAMED6424-M-1 EUDAMED6424-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863696102 EUDAMED04719863696096 EUDAMED04711769146071 EUDAMED04711769146088 EUDAMED
- Basic UDI-DI
- 471986369CL107DR EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Retractor 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 | 471986369CL107DR | 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 (4)
- EUDAMED e013ddf6-39a9-4b75-9678-2aac9b0f69b5 61 fields · synced Oct 6, 2026
- EUDAMED f8a6fdf4-3370-41bd-beae-13718f44cdbf 61 fields · synced May 18, 2026
- EUDAMED a980995b-7864-4fd1-9a78-7803718694ba 61 fields · synced May 18, 2026
- EUDAMED 37eadcf9-b150-4c0d-ae7c-3ccc607f7bda 61 fields · synced May 18, 2026