Identity
- Trade Name
- AXP EUDAMEDAXP Disposable Processing Bagset FDA UDI
- Generic Name
- Cryobiological storage container FDA UDI
- Device Name
- AXP Processing Bag set EUDAMEDCord blood processing system and storage container FDA UDI
- Model / Reference
- 8-5101 EUDAMEDFDA UDI
- Description
- Cord blood processing system and storage container FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10886368000305 EUDAMED00886368000308 FDA UDI
- Basic UDI-DI
- 088636AXPIIPBSMY 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Axp 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 | 088636AXPIIPBSMY | 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 864e0cdf-d616-43fb-ab17-c1b63996e67d 61 fields · synced May 31, 2026
- FDA UDI 62d507a8-f0ab-4595-a2c2-2ccfa4eb48d7 36 fields · synced May 30, 2026