Identity
- Trade Name
- Sigma Transwab FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- Sigma Transwab EUDAMEDSigma Transwab, Sigma swab ENT, 2 ml liquid amies FDA UDI
- Model / Reference
- MW177S2ML EUDAMEDAmies FDA UDI
- Description
- Sigma Transwab, Sigma swab ENT, 2 ml liquid amies FDA UDI
Identifiers
- Catalog Number
- MW177S2ML FDA UDI
- Primary DI / UDI-DI
- 05060259070457 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060259070457 EUDAMED
- FDA Product Code
- JTW 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 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
Category: General-purpose absorbent tip applicator/swab, single-use
Sigma Transwab by Medical Wire & Equipment Co Bath (Ltd) — Class I — 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
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-05060259070457 | 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 (2)
- EUDAMED bcbd6510-5549-454b-b57d-b02927bfd2da 61 fields · synced Jul 19, 2026
- FDA UDI 1f1375fc-cbc5-4cce-b078-36f464280c59 35 fields · synced May 29, 2026