Identity
- Trade Name
- BIO1-C4-18-120 EUDAMED
- Device Name
- BIO1-Series EUDAMED
- Model / Reference
- BIO1-C4-18-120 EUDAMED70100146676 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503022257 EUDAMED
- Basic UDI-DI
- B-04044503022257 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-C4-18-120 by FUJIFILM medwork GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic biopsy forceps, single-use.
- Disposable Biopsy Forceps — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class IIa
- Single Use Biopsy Forceps — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class I
- Disposable Endoscopic Biopsy Forceps — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- POWER-ENDO — Jiangsu Power-endo Medical Technology Co., Ltd · Class IIa
- Single Use Biopsy Forceps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Single-use Biopsy Forceps — Anrei Medical (HZ) CO., LTD. · Class IIa
- 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-04044503022257 | Class IIa | 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 af755360-98b5-47f6-bbfb-d9275843f156 61 fields · synced Jun 18, 2026