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15ml KwikVial Oral Liquid Container
EUDAMEDFDA UDIClass I (EU MDR)
Ref 30015Model KwikVial Container
Identity
- Trade Name
- 15ml KwikVial Oral Liquid Container EUDAMEDKwikVial Container FDA UDI
- Generic Name
- Medicine cup, single-use FDA UDI
- Device Name
- KwikVial Oral Liquid Container EUDAMEDOral liquid dose dispenser FDA UDI
- Model / Reference
- KwikVial Container EUDAMED30015 EUDAMEDFDA UDI
- Description
- Oral liquid dose dispenser FDA UDI
Identifiers
- Catalog Number
- 30015 FDA UDI
- Primary DI / UDI-DI
- 00853832007019 EUDAMEDFDA UDI
- Basic UDI-DI
- 0085383200710007W EUDAMED
- FDA Product Code
- KYX FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- Medicine cup, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 15 Milliliter FDA UDI
15ml KwikVial Oral Liquid Container by MedSafety Solutions — 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 | 0085383200710007W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MedSafety Solutions
- EUDAMED SRN
- US-MF-000008537
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c4d96255-bb35-4013-9b42-1756d0d290d9 61 fields · synced Jun 19, 2026
- FDA UDI 3488c32e-a546-4aa2-a3d9-2e7702929232 36 fields · synced May 30, 2026