Identity
- Trade Name
- Endoscopic Injection Needle EUDAMEDZKSK FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Endoscopic Injection Needle EUDAMEDFDA UDI
- Model / Reference
- SN18-07/230 EUDAMEDFDA UDI
- Description
- Endoscopic Injection Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415066488 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934415066488 EUDAMED
- 510(k) Number
- K213239 FDA UDI
- FDA Product Code
- FBK FDA UDI
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Endoscopic Injection Needle by Beijing ZKSK Technology Co., Ltd — Class IIa — 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-06934415066488 | 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 f85aa1dc-7a99-43f2-acb1-ffc855290770 61 fields · synced Jun 19, 2026
- FDA UDI 1e7a20e8-c50d-4d93-bc54-53f7fb719b3c 35 fields · synced May 30, 2026