Identity
- Trade Name
- 15 Microliters MICROSAFE, 2000 tubes EUDAMEDMICROSAFE FDA UDI
- Generic Name
- Capillary blood collection tube IVD, lithium heparin FDA UDI
- Device Name
- MICROSAFE EUDAMEDMICROSAFE, 15 ul FDA UDI
- Model / Reference
- 1015 EUDAMEDFDA UDI
- Description
- MICROSAFE, 15 ul FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08500594200722 EUDAMED00850059420072 FDA UDI
- Basic UDI-DI
- 0850059420MICROSAF8090NR EUDAMED
- FDA Product Code
- GIO FDA UDI
- EMDN Code
- W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMED
- GMDN Term
- Capillary blood collection tube IVD, lithium heparin FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
15 Microliters MICROSAFE, 2000 tubes by Drummond Scientific Company — 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 | 0850059420MICROSAF8090NR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Drummond Scientific Company
- EUDAMED SRN
- US-MF-000039345
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 21050944-3e4a-4678-8616-5ac317215cb9 61 fields · synced Jul 24, 2026
- FDA UDI bb0afc7b-e710-453a-b71f-da67779c7170 33 fields · synced May 30, 2026