Sigma Virocult
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Sigma Virocult FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- Sigma Virocult EUDAMEDSigma Virocult 3 x swabs with breakpoint, large vial FDA UDI
- Model / Reference
- M400001 EUDAMED501355 EUDAMEDMW951HF EUDAMEDMW951PFENT1ML EUDAMEDMW950S3 EUDAMEDMW951T EUDAMEDN/a FDA UDI
- Description
- Sigma Virocult 3 x swabs with breakpoint, large vial FDA UDI
Identifiers
- Catalog Number
- MW950S3 FDA UDI
- Primary DI / UDI-DI
- 05060259076299 EUDAMED05060259076084 EUDAMED05060259075650 EUDAMED05060259070907 EUDAMED05060259070518 EUDAMEDFDA UDI05060259070570 EUDAMED
- Basic UDI-DI
- B-05060259076299 EUDAMEDB-05060259076084 EUDAMEDB-05060259075650 EUDAMEDB-05060259070907 EUDAMEDB-05060259070518 EUDAMEDB-05060259070570 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
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IVD General EUDAMED
- Regulation Number
- 866.2900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Administering Medicine
No
Measuring Function
No
Surgical Instrument
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-purpose absorbent tip applicator/swab, single-use
Sigma Virocult by Medical Wire & Equipment Co Bath (Ltd) — Class I — IVDD, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
- Disposable Collection Tubes of Virus Samples — Jiangsu Mole Bioscience Co., LTD. · Class A
- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
- Disposable sampling swab — Jiangsu HanHeng Medical Technology Co., Ltd. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060259076299 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05060259076299 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Wire & Equipment Co Bath (Ltd)
- EUDAMED SRN
- GB-MF-000006736
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (7)
- EUDAMED adc5f1f9-ea02-4c79-96b0-2447e6f7be03 61 fields · synced Jul 20, 2026
- EUDAMED aed37518-edf3-44c0-b4f2-362e25f065e5 61 fields · synced May 16, 2026
- EUDAMED 6f7d2ca3-5a16-4322-9b42-7129f2e693cf 61 fields · synced May 17, 2026
- EUDAMED 1cef1775-0505-4a6b-a359-2efd579c9308 61 fields · synced May 17, 2026
- EUDAMED 9c327e25-d272-4dd1-9479-631dc516593c 61 fields · synced May 18, 2026
- EUDAMED 5b122ff6-422d-4902-943c-b2cb853cdc50 61 fields · synced May 18, 2026
- FDA UDI 7dcf62a7-9ae4-482e-bfbd-70bbd9b79115 36 fields · synced May 29, 2026