Identity
- Trade Name
- V-ICSIPET Holding EUDAMEDFDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- V-ICSIPET HOLDING EUDAMEDV-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. For fixing the oocyte or embryos in the implementation of an ICSI or biopsy. FDA UDI
- Model / Reference
- V-HOLD-00 EUDAMEDV-ICSIPET HOLDING 0 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. For fixing the oocyte or embryos in the implementation of an ICSI or biopsy. FDA UDI
Identifiers
- Catalog Number
- V-HOLD-00 FDA UDI
- Primary DI / UDI-DI
- 04260531792119 EUDAMED04260531792126 FDA UDI
- Basic UDI-DI
- B-04260531792119 EUDAMED
- FDA Product Code
- PUC FDA UDI
- EMDN Code
- U0802030105 HOLDING 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 Holding 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-04260531792119 | 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 d9e4ff64-1df3-4db7-8fc6-2db89ad6b4e9 61 fields · synced May 31, 2026
- FDA UDI 5eff213f-3d0b-434f-9756-f2496b2b5032 34 fields · synced May 30, 2026