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Endoscopic Injection Needle
EUDAMEDClass IIa (EU MDR)
Ref SN18-(05/160;200;230,07/160;195;200;230,09/160;200;230),SN19-(05;07)/230
Identity
- Trade Name
- Endoscopic Injection Needle EUDAMED
- Device Name
- Endoscopic Injection Needle EUDAMED
- Model / Reference
- SN18-(05/160;200;230,07/160;195;200;230,09/160;200;230),SN19-(05;07)/230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SN18MH EUDAMED
- Basic UDI-DI
- B-SN18MH EUDAMED
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
Classification
- Device Class
- Class IIa 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
Endoscopic Injection Needle by Beijing ZKSK Technology Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-SN18MH | 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 (2)
- EUDAMED 85b0a95f-94c9-4b0e-8024-7a5aa570928f 61 fields · synced Oct 6, 2026
- EUDAMED 85b0a95f-94c9-4b0e-8024-7a5aa570928f-1 61 fields · synced Jun 10, 2026