Identity
- Trade Name
- Blastomere Biosy Pipette FDA UDI
- Generic Name
- User-induced micropipette FDA UDI
- Model / Reference
- 14343 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350025912117 FDA UDI
- 510(k) Number
- K022643 FDA UDI
- FDA Product Code
- MQH FDA UDI
- GMDN Term
- User-induced micropipette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Blastomere Biosy Pipette by Vitrolife Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (1)
- FDA UDI 9012a96e-ad68-4081-8b4c-79ed7cca2db7 34 fields · synced Jun 1, 2026