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Disposable Polypectomy Snare
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ES18-E1815/2400
Identity
- Trade Name
- Disposable Polypectomy Snare EUDAMEDZKSK FDA UDI
- Generic Name
- Mechanical-cutting endoscopic polypectomy snare FDA UDI
- Device Name
- Disposable Polypectomy Snare EUDAMEDFDA UDI
- Model / Reference
- ES18-E1815/2400 EUDAMEDFDA UDI
- Description
- Disposable Polypectomy Snare FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415066150 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934415066150 EUDAMED
- 510(k) Number
- K213222 FDA UDI
- FDA Product Code
- FDI FDA UDI
- EMDN Code
- G03030101 POLYPECTOMY SNARES, REVOLVING EUDAMED
- GMDN Term
- Mechanical-cutting endoscopic polypectomy snare FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Disposable Polypectomy Snare by Beijing ZKSK Technology Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934415066150 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 a798759d-25f5-43a0-af88-1a8e7d40b52a 61 fields · synced Jun 19, 2026
- FDA UDI 962bfca8-9fbe-4c4a-998d-4a6970d7d760 35 fields · synced May 30, 2026