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Chemiluminescent Substrate
EUDAMEDClass A (EU MDR)
Ref 100mL×1Model 50mL×1,100mL×1,200mL×1, 500mL×1, 1L×1
Identity
- Trade Name
- Chemiluminescent Substrate EUDAMED
- Device Name
- Chemiluminescent Substrate EUDAMED
- Model / Reference
- 50mL×1,100mL×1,200mL×1, 500mL×1, 1L×1 EUDAMED100mL×1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424228085 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 (1)
- EUDAMED 604e4c41-5764-48ce-a061-618f037e1a33 61 fields · synced Jun 17, 2026