Identity
- Trade Name
- V-ICSIPET INJECTION EUDAMEDFDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- V-ICSIPET INJECTION EUDAMEDV-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET pipettes for the manipulation of cells with the help of a micromanipulator. For intracytoplasmic injection (ICSI) of a single sperm into the oocyte (with and without spike). FDA UDI
- Model / Reference
- V-INJ-S3-25 EUDAMEDV-ICSIPET Injection with Spike 25 FDA UDI
- Description
- V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET pipettes for the manipulation of cells with the help of a micromanipulator. For intracytoplasmic injection (ICSI) of a single sperm into the oocyte (with and without spike). FDA UDI
Identifiers
- Catalog Number
- V-INJ-S3-25 FDA UDI
- Primary DI / UDI-DI
- 04260531791150 EUDAMED04260531790337 FDA UDI
- Basic UDI-DI
- B-04260531791150 EUDAMED
- FDA Product Code
- PUC FDA UDI
- EMDN Code
- U0802030106 ICSI PIPETTES EUDAMED
- GMDN Term
- Assisted reproduction microtool FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6130 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
V-Icsipet Injection by VITROMED GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260531791150 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VITROMED GmbH
- EUDAMED SRN
- DE-MF-000005131
Sources (2)
- EUDAMED 9ef9cf79-e5db-4dff-9778-90007f5cc789 61 fields · synced May 31, 2026
- FDA UDI b5dc72fe-384d-4473-8557-4b7848254302 34 fields · synced May 30, 2026