Identity
- Device Name
- Amnioscope 14 CM 32×40 mm EUDAMED
- Model / Reference
- ACC32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701584300018 EUDAMED
- Basic UDI-DI
- 37015843AMNIOFW EUDAMED
- EMDN Code
- Z12029001 AMNIOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Amnioscope 14 CM 32×40 mm by Cie Concorde Import Export — 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 | 37015843AMNIOFW | Class I | Active |
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Manufacturer
- Manufacturer
- Cie Concorde Import Export
- EUDAMED SRN
- FR-MF-000003576
Sources (1)
- EUDAMED e92c75e2-e986-4abd-8f2e-b185b61c4566 61 fields · synced Jun 20, 2026