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PepsinogenⅠ Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kitRef 215270007Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitRef 100tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit
Identity
- Device Name
- PepsinogenⅠ Chemiluminescence Immunoassay Kit EUDAMEDPepsinogenⅡ Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215270007 EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719604661 EUDAMED06972719600878 EUDAMED06972719602933 EUDAMED06972719602940 EUDAMED06972719604678 EUDAMED06972719602971 EUDAMED
- Basic UDI-DI
- B-06972719604661 EUDAMEDB-06972719600878 EUDAMEDB-06972719602933 EUDAMEDB-06972719602940 EUDAMEDB-06972719604678 EUDAMEDB-06972719602971 EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary 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
PepsinogenⅠ Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech 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-06972719604661 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 2803c616-c4ad-4887-97af-73550a38a390 61 fields · synced Oct 6, 2026
- EUDAMED 4e59594f-018c-46a1-b2cf-428f6a8eb735 61 fields · synced May 17, 2026
- EUDAMED 1856233f-1130-48a7-ae9c-4a6501ed1d71 61 fields · synced May 17, 2026
- EUDAMED c376e00b-0786-4c09-9d6a-76cb815a06b1 61 fields · synced May 17, 2026
- EUDAMED 5d7cd925-911e-40fe-b3c3-6dc4494ac564 61 fields · synced May 18, 2026
- EUDAMED 3a2e3cb9-6db5-46e0-b851-4e76cde91940 61 fields · synced May 19, 2026