Identity
- Trade Name
- POL1-B9-10-23-220-OL EUDAMED
- Device Name
- POL1-Series EUDAMED
- Model / Reference
- 70100146687 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503055446 EUDAMED
- Basic UDI-DI
- 40445030564349 EUDAMED
- EMDN Code
- G03030102 POLYPECTOMY SNARES, NON-REVOLVING EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Pol1-B9-10-23-220-Ol by FUJIFILM medwork GmbH — Class IIb — 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 | 40445030564349 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (1)
- EUDAMED 6dce5e5b-838d-4ee0-8a2c-331a21a914db 61 fields · synced Jun 19, 2026