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Micrototal Protein (MT-P) Pyrogallol - Red
EUDAMEDClass IVD General (EU MDR)
Ref D-634 002 Ref D-634 001Ref D-634 003
Identity
- Trade Name
- Micrototal Protein (MT-P) Pyrogallol - Red EUDAMED
- Device Name
- Micrototal Protein (MT-P) Pyrogallol - Red EUDAMED
- Model / Reference
- D-634 002 EUDAMEDD-634 001 EUDAMEDD-634 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182700348 EUDAMED62230182700270 EUDAMED62230182700416 EUDAMED
- Basic UDI-DI
- B-62230182700348 EUDAMEDB-62230182700270 EUDAMEDB-62230182700416 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Micrototal Protein (MT-P) Pyrogallol - Red by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-62230182700348 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 5d3ad7fe-fcc0-491a-a390-be2fa11a2c26 61 fields · synced Jul 20, 2026
- EUDAMED deb8dac8-2d77-4af2-abb2-8c9e179b6d49 61 fields · synced May 17, 2026
- EUDAMED 58d1ad13-bdb1-4b23-901a-36cc4f9e633d 61 fields · synced May 18, 2026