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INNODX ProGRP CMIA
EUDAMEDClass C (EU MDR)
Ref KR-ProGRP-02200Ref KR-ProGRP-05100Ref KR-ProGRP-0250Ref KR-ProGRP-01100
Identity
- Trade Name
- INNODX ProGRP CMIA EUDAMED
- Device Name
- INNODX ProGRP CMIA EUDAMED
- Model / Reference
- KR-ProGRP-02200 EUDAMEDKR-ProGRP-05100 EUDAMEDKR-ProGRP-0250 EUDAMEDKR-ProGRP-01100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799756 EUDAMED06973600799770 EUDAMED06973600799749 EUDAMED06973600798957 EUDAMEDD-KR-ProGRP-05100UM EUDAMEDD-KR-ProGRP-01100TR EUDAMED
- Basic UDI-DI
- 697360079024JV EUDAMEDB-KR-ProGRP-05100UM EUDAMEDB-KR-ProGRP-01100TR EUDAMED
- EMDN Code
- W0102030121 PRO-GASTRIN-RELEASING PEPTIDE EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Belgium EUDAMEDSpain 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
New Device
No
EUDAMED
INNODX ProGRP CMIA by Xiamen Innodx Biotech 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 | 697360079024JV | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079024JV | Class C | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (6)
- EUDAMED 516db13b-bd70-4f5c-a88d-562e5be26b9d 61 fields · synced Oct 6, 2026
- EUDAMED f3bd119a-2b80-4080-ab6d-d33643036d56 61 fields · synced May 17, 2026
- EUDAMED ae624579-011d-4c57-9054-8ef2b215cda6 61 fields · synced May 17, 2026
- EUDAMED e39bc996-a439-49f1-91eb-1239dbd753ee 61 fields · synced May 18, 2026
- EUDAMED 2282f562-d9b2-4a11-b856-86a6dd577406 61 fields · synced Jul 9, 2026
- EUDAMED 3eaac87f-0c7b-41e8-ac6f-e2a0814cb22c 61 fields · synced Jul 10, 2026