← Back to catalogue
Endoscopic Injection Needle
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SN18-07/200
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
- SN18-07/200 EUDAMEDFDA UDI
- Description
- Endoscopic Injection Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415066471 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934415066471 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 — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K213239 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06934415066471 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 036dac31-f70b-4d01-ac64-f2774191a154 61 fields · synced Oct 6, 2026
- FDA UDI 1a049f1a-cf0a-42b9-b7ad-2b2dcde2a8ff 35 fields · synced May 30, 2026
- FDA 510(k) K213239 1 fields · synced May 18, 2026