Identity
- Trade Name
- Guard RMS EUDAMED
- Device Name
- 1-Guard EUDAMED
- Model / Reference
- 10018000/R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760312990372 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
Guard RMS by Poirot Plastique Industrie Médical — 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 | 37603129910018000OBCB | Class I | Active |
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Manufacturer
- Manufacturer
- Poirot Plastique Industrie Médical
- EUDAMED SRN
- FR-MF-000023833
Sources (1)
- EUDAMED e9dfd76f-4917-42cd-9e3e-77d8940a9fa0 61 fields · synced Oct 6, 2026