Identity
- Trade Name
- SafeTrace Tx EUDAMEDFDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- SafeTrace Tx EUDAMEDSafeTrace Tx version 4.x.x FDA UDI
- Model / Reference
- SafeTrace Tx EUDAMED4.x.x FDA UDI
- Description
- SafeTrace Tx version 4.x.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812747010224 EUDAMED00812747010033 EUDAMEDFDA UDI
- Basic UDI-DI
- 081274701HSS0012P EUDAMED
- FDA Product Code
- MMH FDA UDI
- EMDN Code
- Z121799 BLOOD TRANSFUSION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Blood bank information system application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9165 FDA UDI
- Special Device Type
- Software EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
SafeTrace Tx by Haemonetics Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081274701HSS0012P | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Haemonetics Corporation
- EUDAMED SRN
- US-MF-000034539
- Authorised Representative
- Haemonetics Italia s.r.l IT-AR-000021067
Sources (3)
- EUDAMED 9e02cbec-3da2-47b1-b0a3-f29d2393256c 61 fields · synced Jul 18, 2026
- EUDAMED 7e70624e-7dc3-4546-9ed6-5cbe595288ba 61 fields · synced May 19, 2026
- FDA UDI 11e53386-4ccb-4020-ac7f-a571dbd58289 35 fields · synced May 30, 2026