Identity
- Trade Name
- VACUSERA EUDAMED
- Device Name
- VACUSERA® Blood Collection Needle EUDAMED
- Model / Reference
- 261021K EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M712261021K1K EUDAMED
- Basic UDI-DI
- ++M712250NEEDLEAQ EUDAMED
- Direct Marketing DI
- +M712261021K1K EUDAMED
- EMDN Code
- A01010502 NEEDLES FOR COLLECTION UNDER VACUUM, W/O SAFETY SYSTEMS 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vacusera by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. — 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 | ++M712250NEEDLEAQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000025066
Sources (1)
- EUDAMED 696ceaeb-e8ce-40b1-aac5-0ad33664af25 61 fields · synced Jun 19, 2026