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PINP CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMS0710Model AutoLumo analyzerRef CMS0703Ref CMS0705
Identity
- Trade Name
- PINP CLIA Microparticles EUDAMED
- Device Name
- PINP CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMS0710 EUDAMEDCMS0703 EUDAMEDCMS0705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359525275 EUDAMED06942359542562 EUDAMED06942359542586 EUDAMED
- Basic UDI-DI
- 697015090000139HG EUDAMED
- EMDN Code
- W0102060317 PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
PINP CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class B — 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 | 697015090000139HG | Class B | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 4771aaae-f245-4d6e-8af1-8d008110046c 61 fields · synced Jul 23, 2026
- EUDAMED 806bbeda-33f2-439c-96cc-aafcd5bc1536 61 fields · synced May 17, 2026
- EUDAMED 0271c3ac-5c84-47f8-a044-80772d85912f 61 fields · synced May 17, 2026