Identity
- Trade Name
- Multi-Band Ligator EUDAMEDZKSK FDA UDI
- Generic Name
- Oesophageal endoscopic ligator, single-use FDA UDI
- Device Name
- Multi-Band Ligator EUDAMEDFDA UDI
- Model / Reference
- BL18-7A EUDAMEDFDA UDI
- Description
- Multi-Band Ligator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415066662 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934415066662 EUDAMED
- 510(k) Number
- K213223 FDA UDI
- FDA Product Code
- MND FDA UDIFHN FDA UDI
- EMDN Code
- G03020301 LIGATURE SYSTEMS, OESOPHAGEAL VARICES EUDAMED
- GMDN Term
- Oesophageal endoscopic ligator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Multi-Band Ligator by Beijing ZKSK Technology Co., Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, 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 | K213223 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06934415066662 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 290cdb10-b62d-4a7d-92d1-27cb4ee26e86 61 fields · synced Oct 8, 2026
- FDA UDI 37eb9ec5-5eec-4fb2-9548-d593012e768e 35 fields · synced May 30, 2026
- FDA 510(k) K213223 1 fields · synced May 18, 2026