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XpressTrak
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6-00-066Model XpressTrak Software
Identity
- Trade Name
- XpressTrak EUDAMEDXpresstrak Software Kit FDA UDI
- Generic Name
- Cryobiological storage container FDA UDI
- Device Name
- XpressTrak Software EUDAMEDAXP Accessory FDA UDI
- Model / Reference
- XpressTrak Software EUDAMED6-00-066 EUDAMED7-00-288 FDA UDI
- Description
- AXP Accessory FDA UDI
Identifiers
- Catalog Number
- 7-00-288 FDA UDI
- Primary DI / UDI-DI
- 00886368000513 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886368AXPXTSWGE EUDAMED
- FDA Product Code
- OAO FDA UDI
- EMDN Code
- B0105 UMBILICAL CORD BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS EUDAMED
- GMDN Term
- Cryobiological storage container FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
XpressTrak by Thermogenesis Corp. — Class I — 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 | 0886368AXPXTSWGE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thermogenesis Corp.
- EUDAMED SRN
- US-MF-000014232
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 87e72a5f-6b76-4e8b-a4e9-2729199e7c83 61 fields · synced Jul 14, 2026
- FDA UDI 6deb5d62-44ba-439a-a29e-72cdeb334860 36 fields · synced May 30, 2026