Identity
- Device Name
- Vial Adapter EUDAMED
- Model / Reference
- VA-1F20L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 46975124930101 EUDAMED
- Basic UDI-DI
- 697512493VA2W EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Vial Adapter by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222718 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697512493VA2W | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Qiantang Longyue Biotechnology Co., LTD
- EUDAMED SRN
- CN-MF-000028276
- FDA Applicant
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (2)
- EUDAMED d474b75b-a720-4a5d-89e9-96ccb2f72514 85 fields · synced Jun 18, 2026
- FDA 510(k) K222718 1 fields · synced May 18, 2026