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HemosIL D-Dimer HS 500 Controls
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0020013100
Identity
- Trade Name
- HemosIL D-Dimer HS 500 Controls EUDAMEDFDA UDIHemosIL D-Dimer HS 500 Controls (Liquid) FDA UDI
- Generic Name
- D-dimer IVD, control FDA UDI
- Device Name
- HemosIL D-Dimer HS 500 Controls EUDAMEDFDA UDIHemosIL D-Dimer HS 500 Controls (Liquid) FDA UDI
- Model / Reference
- 0020013100 EUDAMED00020500200 FDA UDI00020013100 FDA UDI
- Description
- HemosIL D-Dimer HS 500 Controls FDA UDIHemosIL D-Dimer HS 500 Controls (Liquid) FDA UDI
Identifiers
- Catalog Number
- 00020500200 FDA UDI00020013100 FDA UDI
- Primary DI / UDI-DI
- 08426950584933 EUDAMEDFDA UDI08426950482970 FDA UDI
- Basic UDI-DI
- 8426950584933AB EUDAMED
- Direct Marketing DI
- 08426950584933 EUDAMED
- FDA Product Code
- GGN FDA UDI
- EMDN Code
- W0103020702 CONTROL PLASMA FOR HAEMOSTASIS EUDAMED
- GMDN Term
- D-dimer IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot 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
Yes
EUDAMED
Animal Tissues
Yes
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
Prescription Use
Yes
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: D-dimer IVD, control
HemosIL D-Dimer HS 500 Controls by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (3)
- FDA UDI 330f407f-04f8-4e87-8955-cebd3bff1913 37 fields · synced Jul 11, 2026
- FDA UDI 61b92614-4ca6-41eb-990e-277a68a22b8a 38 fields · synced May 30, 2026
- EUDAMED 47f714c0-9473-42b7-b846-54efdfcba36e 61 fields · synced Jul 11, 2026