Identity
- Trade Name
- AXP Device EUDAMEDAXP Docking Station FDA UDI
- Generic Name
- Cryobiological storage container FDA UDI
- Device Name
- AXP Device EUDAMEDCord blood processing system docking station FDA UDI
- Model / Reference
- AXP Device EUDAMED8-5103 EUDAMEDFDA UDI
- Description
- Cord blood processing system docking station FDA UDI
Identifiers
- Catalog Number
- 8-5103 FDA UDI
- Primary DI / UDI-DI
- 10886368000367 EUDAMED00886368000360 FDA UDI
- Basic UDI-DI
- 088636AXPDSEP EUDAMED
- Direct Marketing DI
- 00886368000360 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AXP Device by Thermogenesis Corp. — Class IIa — 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 | 088636AXPDSEP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 15b611cb-61c8-4e91-a3f3-453707e59820 61 fields · synced Aug 2, 2026
- FDA UDI 843325ae-33d4-4104-806d-13f3c6acf17f 36 fields · synced May 30, 2026