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Chemiluminescent Substrate
EUDAMEDClass A (EU MDR)
Ref DC200402EModel 50mL×1,100mL×1,200mL×1, 500mL×1, 1L×1Ref DC200405ERef DC200403ERef DC200401E
Identity
- Trade Name
- Chemiluminescent Substrate EUDAMED
- Device Name
- Chemiluminescent Substrate EUDAMED
- Model / Reference
- 50mL×1,100mL×1,200mL×1, 500mL×1, 1L×1 EUDAMEDDC200402E EUDAMEDDC200405E EUDAMEDDC200403E EUDAMEDDC200401E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424228139 EUDAMED06975424228122 EUDAMED06975424228108 EUDAMED06975424228115 EUDAMED
- Basic UDI-DI
- 697542422SUBSTRATECT EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Chemiluminescent Substrate by DiYaLab ZJG Biotech 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 | 697542422SUBSTRATECT | Class A | Active |
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Manufacturer
- Manufacturer
- DiYaLab ZJG Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000048648
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 11cb4095-f7ae-401d-9641-9a686cff6182 61 fields · synced Jul 16, 2026
- EUDAMED a6133dfa-eed4-43b1-b8a7-36644ae74c7b 61 fields · synced May 17, 2026
- EUDAMED 55bbb219-e39b-409e-9328-705be513da5d 61 fields · synced May 18, 2026
- EUDAMED 2695e002-2fc8-4693-9a1e-46edb0063453 61 fields · synced May 18, 2026