← Back to catalogue
Pepsinogen Ⅰ (PG Ⅰ) Assay Kit (Chemiluminescent Microparticle Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref "REF: USIA00000123M, USIA00000124M"
Identity
- Device Name
- Pepsinogen Ⅰ (PG Ⅰ) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- "REF: USIA00000123M, USIA00000124M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-67AS EUDAMED
- Basic UDI-DI
- B-6-67AS EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Pepsinogen Ⅰ (PG Ⅰ) Assay Kit (Chemiluminescent Microparticle Immunoassay) by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-6-67AS | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 23843ba1-1011-4626-83f3-e0565e8def53-1 61 fields · synced Oct 8, 2026
- EUDAMED 23843ba1-1011-4626-83f3-e0565e8def53-2 61 fields · synced Jun 19, 2026