Identity
- Device Name
- Cooley Retractor LEFT 24cm 12mm EUDAMED
- Model / Reference
- 10-0656-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+D1061006561600* EUDAMED
- Basic UDI-DI
- ++D106RETRACTORSXE EUDAMED
- EMDN Code
- L03140105 SKIN RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Cooley Retractor LEFT 24cm 12mm by ABI Enterprises — 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 | ++D106RETRACTORSXE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ABI Enterprises
- EUDAMED SRN
- PK-MF-000035328
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 32a66f61-9c40-4336-a3ab-308acaf69a59 61 fields · synced Jun 19, 2026