Identity
- Device Name
- Bailey-Baby EUDAMED
- Model / Reference
- 44-3400-20 EUDAMED44-3400-16 EUDAMED44-3460-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+D106443400200Z* EUDAMED*+D106443400160/* EUDAMED*+D106443460200+* EUDAMED
- Basic UDI-DI
- ++D106CONTRACTORSEF EUDAMED
- EMDN Code
- L0920 ORTHOPAEDIC SURGERY DISTRACTORS, 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
Bailey-Baby 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 | ++D106CONTRACTORSEF | 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 (3)
- EUDAMED b87af2a4-09e8-4878-bc9a-36c6002749e4 61 fields · synced Aug 4, 2026
- EUDAMED a4097bf5-d05a-481f-a654-e802a4aef7c7 61 fields · synced May 17, 2026
- EUDAMED 825bc722-3eb0-4b1c-b094-fa2e57379f7f 61 fields · synced May 18, 2026