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Triglycerides GPO-PAP
EUDAMEDClass IVD General (EU MDR)
Ref D-639 003Ref D-639 001Ref D-639 005Ref D-639 006Ref D-639 002
Identity
- Trade Name
- Triglycerides GPO-PAP EUDAMED
- Device Name
- Triglycerides GPO-PAP EUDAMED
- Model / Reference
- D-639 003 EUDAMEDD-639 001 EUDAMEDD-639 005 EUDAMEDD-639 006 EUDAMEDD-639 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182704544 EUDAMED62230182704308 EUDAMED62230182704780 EUDAMED62230182704858 EUDAMED62230182704476 EUDAMED
- Basic UDI-DI
- B-62230182704544 EUDAMEDB-62230182704308 EUDAMEDB-62230182704780 EUDAMEDB-62230182704858 EUDAMEDB-62230182704476 EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES 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
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
Triglycerides GPO-PAP 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-62230182704544 | 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 (5)
- EUDAMED c0b826b1-9ede-4ebe-8305-ab09309fe072 61 fields · synced Aug 2, 2026
- EUDAMED 2a23858b-dcc3-4623-af81-19b664efb88d 61 fields · synced May 17, 2026
- EUDAMED cb6fe4f7-1daa-400c-9b5d-b3a26ea8ac85 61 fields · synced May 18, 2026
- EUDAMED fca8e7a6-ae37-4274-bc40-758696c103a3 61 fields · synced May 18, 2026
- EUDAMED 7ca341b5-7875-4506-8893-fdd239195654 61 fields · synced May 19, 2026