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pro-Gastrin-Releasing Peptide (eCLIA)
EUDAMEDClass C (EU MDR)
Ref 0320501304Model 50T, 2x50T, 100T, 2x100TModel 2×100T
Identity
- Trade Name
- pro-Gastrin-Releasing Peptide (eCLIA) EUDAMED
- Device Name
- Pro-Gastrin-Releasing Peptide (eCLIA) EUDAMED
- Model / Reference
- 50T, 2x50T, 100T, 2x100T EUDAMED0320501304 EUDAMED2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063508 EUDAMED
- Basic UDI-DI
- 69703416803205051JC EUDAMEDB-06975984063508 EUDAMED
- EMDN Code
- W0102030121 PRO-GASTRIN-RELEASING PEPTIDE EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General 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
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
pro-Gastrin-Releasing Peptide (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69703416803205051JC | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205051JC | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 534e94cf-5f0c-49a8-8b63-609ef78ac272 61 fields · synced Jul 20, 2026
- EUDAMED a1aab68c-4023-40e2-87d2-44689db049a0 61 fields · synced May 19, 2026