Identity
- Trade Name
- HemaSure EUDAMED
- Device Name
- HemaSure-OMICS Blood Stabilization Direct Draw Tube, 250 ul EUDAMED
- Model / Reference
- HemaSure-OMICS-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850040712216 EUDAMED
- Basic UDI-DI
- B-00850040712216 EUDAMED
- EMDN Code
- W0501010199 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HemaSure by Mawi DNA Technologies, LLC — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00850040712216 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Mawi DNA Technologies, LLC
- EUDAMED SRN
- US-MF-000023207
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 9db3280d-3a89-4015-a9bc-ed2a81128658 61 fields · synced Jun 18, 2026