Identity
- Trade Name
- Sigma Virocult FDA UDI
- Generic Name
- Urogenital specimen collection kit IVD, clinical FDA UDI
- Device Name
- Sigma Virocult EUDAMEDMini Sigma Virocult, 1 x Mini Foam 78mm & 1 x Std Foam 79mm FDA UDI
- Model / Reference
- MW951SE2 EUDAMEDN/a FDA UDI
- Description
- Mini Sigma Virocult, 1 x Mini Foam 78mm & 1 x Std Foam 79mm FDA UDI
Identifiers
- Catalog Number
- MW951SE2 FDA UDI
- Primary DI / UDI-DI
- 05060259072611 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060259072611 EUDAMED
- 510(k) Number
- K082472 FDA UDI
- FDA Product Code
- LIO FDA UDI
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
- GMDN Term
- Urogenital specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 866.2900 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Sigma Virocult by Medical Wire & Equipment Co Bath (Ltd) — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060259072611 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medical Wire & Equipment Co Bath (Ltd)
- EUDAMED SRN
- GB-MF-000006736
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 9339b2ea-5af2-4cb0-825c-f9c932596c5f 61 fields · synced Jul 9, 2026
- FDA UDI f83631da-7dc8-4f62-bd28-5b3b4a527cfd 36 fields · synced May 30, 2026