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CHRONO-LOG° Hemostasis Reference Plasma Normal
EUDAMEDClass A (EU MDR)
Ref 299-6Hemostasis Reference Plasma Normal
Identity
- Trade Name
- CHRONO-LOG° Hemostasis Reference Plasma Normal EUDAMED
- Device Name
- Reagents EUDAMED
- Model / Reference
- 299-6Hemostasis Reference Plasma Normal EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811476010024 EUDAMED
- Basic UDI-DI
- 081147601Reagents2YY EUDAMED
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
CHRONO-LOG° Hemostasis Reference Plasma Normal by Chrono-Log Corp — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081147601Reagents2YY | Class A | Active |
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Manufacturer
- Manufacturer
- Chrono-log Corp
- EUDAMED SRN
- US-MF-000018631
- Authorised Representative
- BioTop Medical NL-AR-000012565
Sources (1)
- EUDAMED abe7839f-4d08-404c-92b1-dc84e5dfc7bc 61 fields · synced Jun 19, 2026