Identity
- Trade Name
- Needleless Injector EUDAMED
- Device Name
- Needleless Injector EUDAMED
- Model / Reference
- ZBK WZ-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970494389381 EUDAMED
- Basic UDI-DI
- 697049438ZBKWZ01AE EUDAMED
- Direct Marketing DI
- 16970494389381 EUDAMED
- EMDN Code
- A02010699 INSULIN SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Needleless Injector by Shandong Zhongbaokang Medical Implements 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 | 697049438ZBKWZ01AE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Zhongbaokang Medical Implements Co., Ltd.
- EUDAMED SRN
- CN-MF-000013907
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7f341290-2488-4fa7-9cc4-99524b43d710 61 fields · synced Jun 19, 2026