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Vial Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref 800348Ref 8072108Ref 800327Ref 8072036Ref 8072029
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 TG - VF FDA UDIVA 20mm FLL SIL - VF FDA UDI
- Model / Reference
- 800348 EUDAMED8072108 EUDAMED800327 EUDAMED8072036 EUDAMEDFDA UDI8072029 EUDAMEDFDA UDI
- Description
- Vial Adapter 20mm FLL SIL TG - VF FDA UDIVA 20mm FLL SIL - VF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290108241464 EUDAMED07290108241501 EUDAMED07290108241495 EUDAMED07290108240092 EUDAMEDFDA UDI07290108240580 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 (7)
- EUDAMED 25b292fe-b7c6-4cb6-8165-1ceb926d68c1 61 fields · synced Jul 24, 2026
- EUDAMED a83b1b1b-2a12-4c8a-ac54-ee65a59c7161 61 fields · synced May 17, 2026
- EUDAMED d8b1b3bc-0e96-4056-b3f6-ae4c75696213 61 fields · synced May 18, 2026
- FDA UDI 6791b353-853e-4912-b1e0-bbdc888cc77d 34 fields · synced May 30, 2026
- FDA UDI bca51973-115f-44b9-8ad2-f7b7b4b371d7 34 fields · synced May 30, 2026
- EUDAMED 7573cfd1-b7bd-4301-9a15-ff9448b51095 61 fields · synced Jul 9, 2026
- EUDAMED 3a61ae00-7675-473a-8b1a-97309e53c039 61 fields · synced Jul 24, 2026