Identity
- Device Name
- TOMO IHC Adhesive Glass Slide EUDAMED
- Model / Reference
- ETOM-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04946247469285 EUDAMED
- Basic UDI-DI
- 494624746ETOMMK EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen microscopy slide IVD, single-use
TOMO IHC Adhesive Glass Slide by Matsunami Glass Ind., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 494624746ETOMMK | Class A | Active |
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Manufacturer
- Manufacturer
- Matsunami Glass Ind., Ltd.
- EUDAMED SRN
- JP-MF-000023949
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED bf41013b-9d08-484e-bd1c-ba1242db9652 61 fields · synced Jun 19, 2026