Identity
- Trade Name
- KOVAX-NEEDLE EUDAMED
- Device Name
- Sterile Single Use Needles EUDAMED
- Model / Reference
- 11-627 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806102620151 EUDAMED
- Basic UDI-DI
- 880610260002B9 EUDAMED
- EMDN Code
- A01010199 HYPODERMIC NEEDLES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kovax-Needle by Korea Vaccine 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 | 880610260002B9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Korea Vaccine co., Ltd.
- EUDAMED SRN
- KR-MF-000028066
- Authorised Representative
- Certification Experts NL-AR-000000235
Sources (1)
- EUDAMED e19e1529-604c-47a1-8969-c0cad5172571 61 fields · synced Jul 15, 2026