Identity
- Trade Name
- 1-Guard : ouvre bouche EUDAMED
- Device Name
- 1-Guard EUDAMED
- Model / Reference
- 10018000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760312990013 EUDAMED
- Basic UDI-DI
- 37603129910018000OBCB EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES 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
Category: Gastro-urological guidewire, single-use
1-Guard : ouvre bouche by Poirot Plastique Industrie Médical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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 | 37603129910018000OBCB | Class I | Active |
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Manufacturer
- Manufacturer
- Poirot Plastique Industrie Médical
- EUDAMED SRN
- FR-MF-000023833
Sources (1)
- EUDAMED 274b23f7-c686-4c0c-b9d1-a404e556ac13 61 fields · synced Jun 18, 2026