Identity
- Device Name
- Sterile Hypodermic Needles for Single Use EUDAMED
- Model / Reference
- 21G×1＂ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16944425890192 EUDAMED
- Basic UDI-DI
- 69444258ZSZRW86 EUDAMED
- Unit of Use DI
- 06944425890195 EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Sterile Hypodermic Needles for Single Use by Jiangsu Kangyou Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444258ZSZRW86 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Kangyou Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000027474
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9424a2dd-f17d-4a49-8c96-eb0502ab3af3 61 fields · synced Jun 19, 2026