Identity
- Trade Name
- Disposable Biopsy Forceps EUDAMEDZKSK FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- Disposable Biopsy Forceps EUDAMEDFDA UDI
- Model / Reference
- BF18-B18/120P EUDAMEDFDA UDI
- Description
- Disposable Biopsy Forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415066563 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934415066563 EUDAMED
- FDA Product Code
- FCL FDA UDI
- EMDN Code
- G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Flexible endoscopic biopsy forceps, single-use
Disposable Biopsy Forceps by Beijing ZKSK Technology Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934415066563 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 788e8308-0a0b-4caf-8245-e3920f5da895 61 fields · synced Jun 18, 2026
- FDA UDI 8b142b36-98f3-4b21-a380-ffc3be45c0b6 34 fields · synced May 29, 2026