Identity
- Trade Name
- PAP1-A1-20-OL EUDAMED
- Device Name
- PAP1-Series EUDAMED
- Model / Reference
- 70100146708 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503016034 EUDAMED
- Basic UDI-DI
- 40445030564247 EUDAMED
- EMDN Code
- G03040299 PAPILLOTOMES / SPHINCTEROTOMES - OTHER 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
Pap1-A1-20-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 | 40445030564247 | Class IIb | Active |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (1)
- EUDAMED 0519e4c5-6c9f-4c64-a640-d926c0a325ad 61 fields · synced Jul 8, 2026