← Back to catalogue
Bal1-C2-16-07-200-35
EUDAMEDClass I (EU MDR)
Ref 70100146700Model BAL1-C2-16-07-200-35
Identity
- Trade Name
- BAL1-C2-16-07-200-35 EUDAMED
- Device Name
- BAL1-Series EUDAMED
- Model / Reference
- BAL1-C2-16-07-200-35 EUDAMED70100146700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503016171 EUDAMED
- Basic UDI-DI
- B-04044503016171 EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES 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
Yes
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bal1-C2-16-07-200-35 by FUJIFILM medwork GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04044503016171 | 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 fb882cc5-a928-434c-b4c7-1833d475f404 61 fields · synced Jun 18, 2026