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Smearsafe
EUDAMEDFDA UDIClass A (EU MDR)
Ref BD0101Ref C1000Model 00892159002017
Identity
- Trade Name
- Smearsafe EUDAMEDFDA UDI
- Generic Name
- Blood smearing manual instrument IVD FDA UDI
- Device Name
- Blood dispenser EUDAMEDSmearsafe™ | Blood Dispenser FDA UDI
- Model / Reference
- BD0101 EUDAMED00892159002017 EUDAMEDC1000 EUDAMEDFDA UDI
- Description
- Smearsafe™ | Blood Dispenser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20810050855796 EUDAMED00892159002017 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005085BDABCTP7 EUDAMED0892159002BDABCTWG EUDAMED
- Unit of Use DI
- 00810050855792 EUDAMED00892159002000 EUDAMED
- FDA Product Code
- JRC FDA UDI
- EMDN Code
- W02079003 DISPENSERS EUDAMED
- GMDN Term
- Blood smearing manual instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Italy EUDAMEDPoland 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
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Smearsafe by Typenex Medical, LLC — 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 | 081005085BDABCTP7 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Typenex Medical, LLC
- EUDAMED SRN
- US-MF-000024001
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (3)
- EUDAMED 0a56cc5c-27dd-45bf-ad6f-66c9dd5c5999 61 fields · synced Jul 31, 2026
- EUDAMED 5b0fbe5c-f6b4-4f4a-a7e4-a020976857f7 61 fields · synced May 19, 2026
- FDA UDI 3d54d3c2-9ab6-4b87-b967-36ecf8e3d615 33 fields · synced May 27, 2026