Identity
- Device Name
- MESACUP-2 TEST Desmoglein 1 EUDAMED
- Model / Reference
- 7881E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987506016826 EUDAMED
- Basic UDI-DI
- 498750601682KE EUDAMED
- Direct Marketing DI
- 04987506016826 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
MESACUP-2 TEST Desmoglein 1 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 | 498750601682KE | 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 97e57d58-8bd0-4ec0-8b0b-118541b9013d 61 fields · synced Jul 23, 2026