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Disposable Veress Needles
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 105Y.209Model Model I, Model II510(k) K232401
Identity
- Trade Name
- Disposable Veress Needles EUDAMED
- Device Name
- Disposable Veress Needles EUDAMED
- Model / Reference
- Model I, Model II EUDAMED105Y.209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950465538171 EUDAMED
- Basic UDI-DI
- 69504655105YK2 EUDAMED
- EMDN Code
- K0104 VERESS NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Disposable Veress Needles by Hangzhou Kangji Medical Instrument Co. Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232401 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69504655105YK2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Kangji Medical Instrument Co. Ltd
- EUDAMED SRN
- CN-MF-000008708
- FDA Applicant
- Hangzhou Kangji Medical Instrument Co., Ltd.
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (2)
- EUDAMED 49576cc0-4594-4f17-a864-ba31f51baf2f 85 fields · synced Jun 18, 2026
- FDA 510(k) K232401 1 fields · synced May 18, 2026