Identity
- Trade Name
- V-DENUPET EUDAMEDFDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- V-DENUPET EUDAMEDThe tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures. FDA UDI
- Model / Reference
- V-DEN-600 EUDAMEDV-DENUPET 600 FDA UDI
- Description
- The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures. FDA UDI
Identifiers
- Catalog Number
- V-DEN-600 FDA UDI
- Primary DI / UDI-DI
- 04260531790092 EUDAMEDFDA UDI
- Basic UDI-DI
- 426053179VDENUPET3Q EUDAMED
- FDA Product Code
- MQH FDA UDI
- EMDN Code
- U0802030103 HANDLING 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
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
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
V-Denupet by VITROMED GmbH — Class IIa — 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 | 426053179VDENUPET3Q | 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 1e779d47-4e60-4771-909f-127e4d5a641c 61 fields · synced Jul 21, 2026
- FDA UDI 2b77a7d6-00f2-4c5e-b740-87fc590d7828 34 fields · synced May 27, 2026