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Mswab®
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 404CRef 07007248190Ref 6U019NRef 6E092N01Ref 6E067NRef 6E076N
Identity
- Trade Name
- Mswab EUDAMEDMswab® FDA UDI
- Generic Name
- General specimen collection kit FDA UDI
- Device Name
- MSwab EUDAMED1,6 mL of MSwab® medium + regular FLOQSwabs® FDA UDI
- Model / Reference
- 404C EUDAMEDFDA UDI07007248190 EUDAMED6U019N EUDAMED6E092N01 EUDAMED6E067N EUDAMED6E076N EUDAMED
- Description
- 1,6 mL of MSwab® medium + regular FLOQSwabs® FDA UDI
Identifiers
- Catalog Number
- 404C FDA UDI
- Primary DI / UDI-DI
- 18053326006187 EUDAMED18053326006194 EUDAMED08053326007774 EUDAMED18053326010474 EUDAMED08053326011092 EUDAMED08053326009938 EUDAMED38053326006181 FDA UDI
- Basic UDI-DI
- 80533260BD0360AM0049Y EUDAMED80533260CD0350AM004AE EUDAMED
- 510(k) Number
- K121039 FDA UDI
- FDA Product Code
- JTW FDA UDI
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
- GMDN Term
- General specimen collection kit FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2900 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Surgical Instrument
No
EUDAMED
New Device
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
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 specimen collection kit
Mswab® by Copan Italia Spa — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General specimen collection kit.
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- Centurion — Centurion Medical Products · Class I
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Cleared under the same submission
K121039 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| 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
- Copan Italia Spa
Sources (7)
- FDA UDI 3a0bb95c-163c-4aaf-994c-1c27486f33ed 35 fields · synced Jul 31, 2026
- EUDAMED 9d2a0ffc-87ff-47c8-b2e5-fe71c9fac137 61 fields · synced Jul 9, 2026
- EUDAMED 3181c1cd-46da-41ff-8591-b42a048ca44c 61 fields · synced Jul 9, 2026
- EUDAMED f6ee98f8-03cd-441d-91ba-7a8c13396993 61 fields · synced Jul 9, 2026
- EUDAMED dd2e9f41-a859-4ae3-94ce-f6dd092debb2 61 fields · synced Jul 13, 2026
- EUDAMED 3694d340-ab88-4a16-97e6-a0868a0aa931 61 fields · synced Jul 28, 2026
- EUDAMED aacc251f-7664-4df6-aab3-7347c0915d43 61 fields · synced Jul 31, 2026