Identity
- Trade Name
- Mix2Vial® EUDAMEDMix2Vial Transfer Device FDA UDI
- Generic Name
- Medication transfer needle, filtering FDA UDI
- Device Name
- Mix2Vial® EUDAMEDMix2Vial™ 20/20mm w/15µm Large Filter TG S-Spike FDA UDI
- Model / Reference
- 8074044 EUDAMEDFDA UDI
- Description
- Mix2Vial™ 20/20mm w/15µm Large Filter TG S-Spike FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290108241808 EUDAMED07290108240696 FDA UDI
- Basic UDI-DI
- 729010824M2VCR14H EUDAMED
- 510(k) Number
- K031861 FDA UDI
- FDA Product Code
- LHI FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Medication transfer needle, filtering FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Austria 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
Radiation Sterilization FDA UDI
Mix2Vial® by West Pharma. Services IL, Ltd. — 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 | 729010824M2VCR14H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- West Pharma. Services IL, Ltd.
- EUDAMED SRN
- IL-MF-000008572
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4e7d2bd2-28e6-44c2-a2f0-dbd0f9572170 61 fields · synced Jul 29, 2026
- FDA UDI 0e58cc87-9a55-4131-bc0b-08460e451110 34 fields · synced May 30, 2026