Identity
- Trade Name
- Vial Adapter EUDAMEDFDA UDI
- Generic Name
- Vial/bottle adaptor, non-hermetic FDA UDI
- Device Name
- Vial Adapter™ EUDAMEDVial Adapter 20mm FLL SIL - SF FDA UDI
- Model / Reference
- 8072031 EUDAMEDFDA UDI
- Description
- Vial Adapter 20mm FLL SIL - SF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290108240597 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010824VAT4 EUDAMED
- 510(k) Number
- K001293 FDA UDI
- FDA Product Code
- LHI FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Vial/bottle adaptor, non-hermetic 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
Vial Adapter 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 | 729010824VAT4 | 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 75705175-3cce-4a90-8936-d8e0d3b6e4b9 61 fields · synced Aug 2, 2026
- FDA UDI 2c5d9dea-fa48-4bb0-bef7-f8ad5f54c579 34 fields · synced May 30, 2026