Identity
- Trade Name
- Typesafe 2.0 EUDAMEDFDA UDI
- Generic Name
- Blood donor bag segment sampling IVD FDA UDI
- Device Name
- Blood segment piercing device EUDAMEDTypesafe 2.0 - Quantity 1000 FDA UDI
- Model / Reference
- 4R4750 EUDAMEDSP0201QM EUDAMEDFDA UDI
- Description
- Typesafe 2.0 - Quantity 1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812269031254 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226903BDABBSUU EUDAMED
- Unit of Use DI
- 00812269031257 EUDAMED
- FDA Product Code
- KSS FDA UDI
- EMDN Code
- W02079003 DISPENSERS EUDAMED
- GMDN Term
- Blood donor bag segment sampling IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Market of Registration
- Poland 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
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Typesafe 2.0 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 | 081226903BDABBSUU | 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 (2)
- EUDAMED ffedba4f-3aa3-4b10-ab01-b32fc124b011 61 fields · synced Jul 19, 2026
- FDA UDI 6182c97b-f570-4a96-883f-097aa807906a 34 fields · synced May 30, 2026