Identity
- Trade Name
- AXP EUDAMEDQC Bagset FDA UDI
- Generic Name
- Cryobiological storage container FDA UDI
- Device Name
- AXP QC Bag Set EUDAMEDUtilized for quality control testing of the AXP Device. FDA UDI
- Model / Reference
- AXP QC Bag Set EUDAMED8-5110 EUDAMED70176 FDA UDI
- Description
- Utilized for quality control testing of the AXP Device. FDA UDI
Identifiers
- Catalog Number
- 8-5110 FDA UDI
- Primary DI / UDI-DI
- 10886368000329 EUDAMED00886368000322 FDA UDI
- Basic UDI-DI
- 0886368AXPQCBSAD EUDAMED
- Direct Marketing DI
- 00886368000322 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
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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 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 | 0886368AXPQCBSAD | 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 33fd9ad0-a282-42bb-b2c7-a657070a9a6b 61 fields · synced Jul 15, 2026
- FDA UDI 7cb61118-52a3-4fbb-ac1b-ea365af6ad77 37 fields · synced May 29, 2026