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Pepsinogen Ⅰ Kit (Latex-Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ450YModel 64mL（R1:1×54mL+R2:1×10mL）
Identity
- Trade Name
- Pepsinogen Ⅰ Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Pepsinogen Ⅰ Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 64mL（R1:1×54mL+R2:1×10mL） EUDAMEDMJ450Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750737 EUDAMED
- Basic UDI-DI
- B-06936595750737 EUDAMED
- EMDN Code
- W01010127 PEPSIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Pepsinogen Ⅰ Kit (Latex-Enhanced Immunoturbidimetric Method) by Medicalsystem Biotechnology 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-06936595750737 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5fdb530c-c01c-4824-9ecb-6dcb01b4d212 61 fields · synced Jun 19, 2026