Identity
- Trade Name
- PolyLink EUDAMED
- Device Name
- PolyLink EUDAMED
- Model / Reference
- M-116700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700659400899 EUDAMED
- Basic UDI-DI
- 3700659416709N EUDAMED
- EMDN Code
- Z129012 MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS 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
PolyLink by Sefam — 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 | 3700659416709N | Class I | Active |
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Manufacturer
- Manufacturer
- Sefam
- EUDAMED SRN
- FR-MF-000009061
Sources (1)
- EUDAMED 46f9b52f-ec44-4168-b37c-3f117234f313 61 fields · synced Jul 10, 2026