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AXP Start Up Accessory Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-5100Model AXP Start Up Accessory Kit
Identity
- Trade Name
- Thermogenesis Start Up Accessory Kit, AXP FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Device Name
- AXP Start Up Accessory Kit EUDAMEDThermogenesis Start Up Accessory Kit, AXP FDA UDI
- Model / Reference
- AXP Start Up Accessory Kit EUDAMED8-5100 EUDAMEDFDA UDI
- Description
- Thermogenesis Start Up Accessory Kit, AXP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886368000544 EUDAMEDFDA UDI
- Basic UDI-DI
- 088636AXPSUAKJJ EUDAMED
- FDA Product Code
- OAO FDA UDI
- EMDN Code
- B0105 UMBILICAL CORD BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS EUDAMED
- GMDN Term
- Blood centrifugation system containment kit FDA UDI
Classification
- Device Class
- Class I 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
Yes
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
Yes
FDA UDI
Combination Product
Yes
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
AXP Start Up Accessory Kit 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 | 088636AXPSUAKJJ | 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 8e672182-cb80-4121-be46-d5497e875369 61 fields · synced Jul 17, 2026
- FDA UDI 469b58d0-f16e-4b30-a311-8a79b4eb6d58 36 fields · synced May 30, 2026