Identity
- Trade Name
- BIO1-H4-23-180 EUDAMED
- Device Name
- BIO1-Series EUDAMED
- Model / Reference
- BIO1-H4-23-180 EUDAMED70100146679 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503055767 EUDAMED
- Basic UDI-DI
- B-04044503055767 EUDAMED
- EMDN Code
- G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Category: Flexible endoscopic biopsy forceps, single-use
Bio1-H4-23-180 by FUJIFILM medwork GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Flexible endoscopic biopsy forceps, single-use.
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- Disposable Biopsy Forceps — Jiangsu Ate Medical Technology Co., Ltd. · Class IIa
- Disposable Biopsy Forceps — Endoaccess GmbH · Class IIa
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-04044503055767 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (1)
- EUDAMED e1643321-1d21-4860-929a-77f4ad15857b 61 fields · synced Jun 19, 2026