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Sigma VCM
EUDAMEDClass I (EU MDR)
Ref Sigma VCM™Model M350102Ref M350103Ref MW919PFRef MW918SRef MW912SRef MW911PF2MLRef M350101Ref MW914PF2MLRef MW911S3MLRef MW919SRef MW915TRef MW911HF2MLRef M400010Ref MW910PF2ML
Identity
- Trade Name
- Sigma VCM EUDAMED
- Device Name
- Sigma VCM™ EUDAMEDSIGMA VCM EUDAMED
- Model / Reference
- M350102 EUDAMEDSigma VCM™ EUDAMEDM350103 EUDAMEDMW919PF EUDAMEDMW918S EUDAMEDMW912S EUDAMEDMW911PF2ML EUDAMEDM350101 EUDAMEDMW914PF2ML EUDAMEDMW911S3ML EUDAMEDMW919S EUDAMEDMW915T EUDAMEDMW911HF2ML EUDAMEDM400010 EUDAMEDMW910PF2ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060259075742 EUDAMED05060259075759 EUDAMED05060259079733 EUDAMED05060259070631 EUDAMED05060259070600 EUDAMED05060259074691 EUDAMED05060259075735 EUDAMED05060259079955 EUDAMED05060259076169 EUDAMED05060259070648 EUDAMED05060259070617 EUDAMED05060259075599 EUDAMED05060259072888 EUDAMED05060259074660 EUDAMED
- Basic UDI-DI
- B-05060259075742 EUDAMEDB-05060259075759 EUDAMEDB-05060259079733 EUDAMEDB-05060259070631 EUDAMEDB-05060259070600 EUDAMEDB-05060259074691 EUDAMEDB-05060259075735 EUDAMEDB-05060259079955 EUDAMEDB-05060259076169 EUDAMEDB-05060259070648 EUDAMEDB-05060259070617 EUDAMEDB-05060259075599 EUDAMEDB-05060259072888 EUDAMEDB-05060259074660 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
Sigma VCM by Medical Wire & Equipment Co Bath (Ltd) — Class I — IVDD, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060259075742 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05060259075742 | Class I | Active |
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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 (14)
- EUDAMED 210537ff-f829-470d-af39-d12caf7e1f00 61 fields · synced Oct 6, 2026
- EUDAMED c003ae21-8014-472a-a398-b1b2e7638e02 61 fields · synced May 16, 2026
- EUDAMED 0be55767-c74d-4f6c-ae0b-ca6542fa3443 61 fields · synced May 16, 2026
- EUDAMED 66b83124-f169-4878-81e0-a34e5d371aeb 61 fields · synced May 16, 2026
- EUDAMED 05fec37b-b963-43ea-9ef3-2d27eb613c14 61 fields · synced May 17, 2026
- EUDAMED 7c208b3a-1fdc-4c62-bed6-b91287ebd193 61 fields · synced May 18, 2026
- EUDAMED 9ca970b1-4922-4f91-8863-d56cabced252 61 fields · synced May 18, 2026
- EUDAMED 70348c24-8f59-4e9d-8ebc-55cc4aa357ac 61 fields · synced May 18, 2026
- EUDAMED c303e3a8-3d75-4ea4-ab9d-46797c83e263 61 fields · synced May 18, 2026
- EUDAMED afb7e6ee-ae36-4869-a1f2-dfa349606db7 61 fields · synced May 18, 2026
- EUDAMED f17bb0d1-7b87-4892-a8a2-10a7ed3e623e 61 fields · synced May 18, 2026
- EUDAMED 273fcb8c-b2fe-44b9-bb29-d224ca7afbcc 61 fields · synced May 18, 2026
- EUDAMED b426ae14-fe73-4539-b8e5-fed9dd7dd878 61 fields · synced May 19, 2026
- EUDAMED 45ba5351-3ed4-4810-8f6a-f5be00778ecd 61 fields · synced May 19, 2026