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Doyen
EUDAMEDClass I (EU MDR)
Ref 42-2550-17Ref 65-2022-05Ref 65-2031-01Ref 42-2552-15
Identity
- Device Name
- Doyen EUDAMED
- Model / Reference
- 42-2550-17 EUDAMED65-2022-05 EUDAMED65-2031-01 EUDAMED42-2552-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+D1064225501701* EUDAMED*+D106652022050/* EUDAMED*+D106652031010-* EUDAMED*+D1064225521501* EUDAMED
- Basic UDI-DI
- ++D106GYNECOLOGYTV EUDAMED
- EMDN Code
- L059003 GYNECOLOGICAL USE HOOKS, REUSABLE EUDAMEDL050901 UTERINE CURETTES, 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
Doyen 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 | ++D106GYNECOLOGYTV | Class I | Active |
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Manufacturer
- Manufacturer
- ABI Enterprises
- EUDAMED SRN
- PK-MF-000035328
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED 7fd4be4f-0ec9-4b5e-9519-df004545b4ec 61 fields · synced Jul 19, 2026
- EUDAMED c48efea2-9b99-47a4-bcb4-606c85941cc6 61 fields · synced May 17, 2026
- EUDAMED 18039df0-8e2c-44e2-9e4d-d087e6cd6be5 61 fields · synced May 18, 2026
- EUDAMED a684612f-0c37-4238-b8c8-5863b42c013d 61 fields · synced May 19, 2026