← Back to catalogue
CHRONO-LOG° Hemostasis Reference Plasma Abnormal
EUDAMEDClass A (EU MDR)
Ref 299-7 Hemostasis Reference Plasma Abnormal
Identity
- Trade Name
- CHRONO-LOG° Hemostasis Reference Plasma Abnormal EUDAMED
- Device Name
- Reagents EUDAMED
- Model / Reference
- 299-7 Hemostasis Reference Plasma Abnormal EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811476010031 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 Abnormal 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chrono-log Corp
- EUDAMED SRN
- US-MF-000018631
- Authorised Representative
- BioTop Medical NL-AR-000012565
Sources (1)
- EUDAMED 6bc87482-4f0a-4511-b749-53efde06881f 61 fields · synced Jul 25, 2026