Identity
- Trade Name
- OdonAssist EUDAMED
- Device Name
- OdonAssist EUDAMED
- Model / Reference
- CAT-126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18881300626010 EUDAMED
- Basic UDI-DI
- 8881300626ODONASSISTU2 EUDAMED
- Unit of Use DI
- 08881300626013 EUDAMED
- EMDN Code
- U1004 MANUAL OBSTETRICAL EXTRACTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
OdonAssist by Maternal Newborn Health Innovations Singapore Pte Ltd — 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 | 8881300626ODONASSISTU2 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- SG-MF-000035955
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 3f260cdf-c3c0-499e-b163-dbb9a0819f6c 61 fields · synced Jul 8, 2026