Identity
- Trade Name
- PRO1-K1-05-220-35 EUDAMED
- Device Name
- PRO-Delivery EUDAMED
- Model / Reference
- 70100146797 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503035226 EUDAMED
- Basic UDI-DI
- 4044503060493W EUDAMED
- EMDN Code
- G030499 ERCP AND SPHINCTEROTOMY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Pro1-K1-05-220-35 by FUJIFILM medwork GmbH — 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 | 4044503060493W | Class I | 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 f9fb12e3-c868-438b-bb15-2913f1767922 61 fields · synced Aug 2, 2026