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Microtest M4rt (3ml) Universal Swab Kit Pk/100
EUDAMEDFDA UDIClass A (EU MDR)
Ref R12578
by Remel, Inc.
Identity
- Trade Name
- MICROTEST M4RT (3ML) UNIVERSAL SWAB KIT PK/100 EUDAMEDMicroTest M4RT FDA UDI
- Generic Name
- Microbiological transport medium IVD FDA UDI
- Device Name
- MICROTEST M4RT KIT EUDAMEDM4RT(3ml) Universal Swab Kit PK/100 FDA UDI
- Model / Reference
- R12578 EUDAMEDFDA UDI
- Description
- M4RT(3ml) Universal Swab Kit PK/100 FDA UDI
Identifiers
- Catalog Number
- R12578 FDA UDI
- Primary DI / UDI-DI
- 00848838018534 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380M4RTKitEB EUDAMED
- 510(k) Number
- K965152 FDA UDI
- FDA Product Code
- JSM FDA UDI
- EMDN Code
- W0104010203 TRANSPORT MEDIA EUDAMED
- GMDN Term
- Microbiological transport medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Microtest M4rt (3ml) Universal Swab Kit Pk/100 by Remel, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8488380M4RTKitEB | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED d12f7720-1936-49ff-9fb2-2c787f421d20 61 fields · synced Jun 19, 2026
- FDA UDI 312efea1-8537-4ed7-b52a-87b985734f7a 35 fields · synced May 30, 2026