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Single-use Biopsy Forceps
EUDAMEDClass IIa (EU MDR)
Ref BFTW-1829E-YGModel BFUW-1029P-YG、 BFTW-1629E-YG、BFUW-1629E-YG、BFTW-1829E-YG、 BFTN-1829E-YG、BFUW-1829E-YG、BFUN-1829E-YGRef BFTN-1829E-YGRef BFUW-1629E-YGRef BFUW-1029P-YGRef 06971381258158Ref BFUW-1829E-YG
Identity
- Trade Name
- Single-use Biopsy Forceps EUDAMED
- Device Name
- Single-use Biopsy Forceps EUDAMED
- Model / Reference
- BFUW-1029P-YG、 BFTW-1629E-YG、BFUW-1629E-YG、BFTW-1829E-YG、 BFTN-1829E-YG、BFUW-1829E-YG、BFUN-1829E-YG EUDAMEDBFTW-1829E-YG EUDAMEDBFTN-1829E-YG EUDAMEDBFUW-1629E-YG EUDAMEDBFUW-1029P-YG EUDAMED06971381258158 EUDAMEDBFUW-1829E-YG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381258127 EUDAMED06971381258134 EUDAMED06971381258110 EUDAMED06971381258097 EUDAMED06971381258158 EUDAMED06971381258141 EUDAMED
- Basic UDI-DI
- 697138125036A8V EUDAMED
- Direct Marketing DI
- 06971381258127 EUDAMED06971381258134 EUDAMED06971381258158 EUDAMED06971381258141 EUDAMED
- EMDN Code
- G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Category: Flexible endoscopic biopsy forceps, single-use
Single-use Biopsy Forceps by Scivita Medical Technology Co., Ltd. — Class IIa — MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697138125036A8V | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 49731afd-743c-4e00-91f9-77f0eeed6ab6 61 fields · synced Sep 17, 2026
- EUDAMED 8336fe36-f4c9-45f0-bf10-efd270a0c357 61 fields · synced May 17, 2026
- EUDAMED 10133b81-7973-4c3a-96f2-26359464bb14 61 fields · synced May 17, 2026
- EUDAMED 0f0a99a9-1c5f-4f70-8637-87be3f8fe0a7 61 fields · synced May 18, 2026
- EUDAMED 55508c7e-12ed-4d29-874d-d8091c001bb6 61 fields · synced May 19, 2026
- EUDAMED 0f2d4835-1c5e-49e7-aec2-ace45b2cab68 61 fields · synced May 19, 2026