Identity
- Trade Name
- Typesafe EUDAMEDFDA UDI
- Generic Name
- Blood donor bag segment sampling IVD FDA UDI
- Device Name
- Blood segment piercing device EUDAMEDTypesafe Segment Piercing Device FDA UDI
- Model / Reference
- 4R4750 EUDAMEDFDA UDITS500 FDA UDI
- Description
- Typesafe Segment Piercing Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812269031278 EUDAMEDFDA UDI10812269031285 FDA UDI
- Basic UDI-DI
- 081226903BDABBSUU 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
- Croatia 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 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
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 |
| 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 (3)
- EUDAMED 8b678f6b-86dd-4a46-a077-1ed5bea35bae 61 fields · synced Jun 6, 2026
- FDA UDI 2a8fffa0-3510-48c5-8895-525533a119d1 34 fields · synced May 29, 2026
- FDA UDI eed017e2-0757-451b-9d98-f0faf12697b5 34 fields · synced May 29, 2026