Identity
- Trade Name
- CHRONO-LOG® Optical Aggregometer EUDAMEDChrono-log FDA UDI
- Generic Name
- Platelet aggregation analyser IVD FDA UDI
- Device Name
- CHRONO-LOG® Platelet Aggregation Systems EUDAMEDPlatelet Aggregometer FDA UDI
- Model / Reference
- 490 4+ EUDAMEDFDA UDI
- Description
- Platelet Aggregometer FDA UDI
Identifiers
- Catalog Number
- 490 4+ FDA UDI
- Primary DI / UDI-DI
- 00811476010987 EUDAMEDFDA UDI
- Basic UDI-DI
- 081147601AggregometersGT EUDAMED
- 510(k) Number
- K161329 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- EMDN Code
- W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Platelet aggregation analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5700 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CHRONO-LOG® Optical Aggregometer by Chrono-Log Corp — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081147601AggregometersGT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Chrono-log Corp
- EUDAMED SRN
- US-MF-000018631
- Authorised Representative
- BioTop Medical NL-AR-000012565
Sources (2)
- EUDAMED 65fa127f-dfad-4a00-9078-ef478559e5b6 61 fields · synced Jun 19, 2026
- FDA UDI f40625db-153d-4e52-9f5b-7dba1293ed14 36 fields · synced May 30, 2026