Identity
- Trade Name
- Substrate EUDAMED
- Device Name
- Substrate EUDAMED
- Model / Reference
- 10101002 EUDAMED130mL×4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070763213 EUDAMED
- Basic UDI-DI
- 697507076CLSubstrateZU EUDAMED697507076000309S5 EUDAMED
- Direct Marketing DI
- 06975070763213 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - OTHER 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
Yes
EUDAMEDEUDAMED
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
Substrate by C-Luminary Biotechnology Co., Ltd. — Class A — 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 | 697507076CLSubstrateZU | Class A | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 79c415e3-999d-48d8-96b4-39e943a15eb3 61 fields · synced Jun 18, 2026
- EUDAMED 506a6c31-b2f2-4948-84c2-a9a58c24c291 61 fields · synced Jun 18, 2026