Identity
- Device Name
- HEXAMATE Factor XIII-Control I/II EUDAMED
- Model / Reference
- 04942371R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987506017038 EUDAMED
- Basic UDI-DI
- 498750601703JV EUDAMED
- Direct Marketing DI
- 04987506017038 EUDAMED
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
HEXAMATE Factor XIII-Control I/II by Medical & Biological Laboratories Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 498750601703JV | Class B | Active |
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Manufacturer
- Manufacturer
- Medical & Biological Laboratories Co., Ltd.
- EUDAMED SRN
- JP-MF-000017864
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED ec9748c0-dfee-49e4-82a2-f650be2259d0 61 fields · synced Jul 30, 2026