Identity
- Device Name
- Pre-filled Flush Syringes EUDAMED
- Model / Reference
- ZBKYC03 3ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970494380101 EUDAMED
- Basic UDI-DI
- 697049438ZBKYC0179 EUDAMED
- Direct Marketing DI
- 26970494380101 EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pre-filled Flush Syringes by Shandong Zhongbaokang Medical Implements Co., Ltd. — Class IIa — CE/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 | 697049438ZBKYC0179 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 082fe2c4-3867-4e62-9a88-ac094641a08e 61 fields · synced Oct 7, 2026