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Disposable Hot Biopsy Forceps
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref HF18-(24/60;120;160;180;200;230,18/60;120;160;180;200)510(k) K231721
Identity
- Trade Name
- Disposable Hot Biopsy Forceps EUDAMED
- Device Name
- Disposable Hot Biopsy Forceps EUDAMED
- Model / Reference
- HF18-(24/60;120;160;180;200;230,18/60;120;160;180;200) EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HF18HU EUDAMED
- Basic UDI-DI
- B-HF18HU EUDAMED
- EMDN Code
- G0308010102 GASTROINTESTINAL ENDOSCOPY, HOT BIOPSY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb 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
Disposable Hot Biopsy Forceps by Beijing ZKSK Technology Co., Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231721 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-HF18HU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- FDA Applicant
- Beijing Zksk Technology Co., Ltd.
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 1434ec13-8137-48b3-9292-7dd13d5e8d36 85 fields · synced Oct 6, 2026
- EUDAMED 1434ec13-8137-48b3-9292-7dd13d5e8d36-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K231721 1 fields · synced May 18, 2026