Identity
- Trade Name
- eMRSA Broth EUDAMED
- Device Name
- eMRSA Broth EUDAMED
- Model / Reference
- 086CE01.A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18053326000383 EUDAMED
- Basic UDI-DI
- 80533260BD0310AM0047B EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
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
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen collection kit
eMRSA Broth by Copan Italia S.P.A. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General specimen collection kit.
- TUD NA CITRATE 0.109M 3ML — TUD SDN BHD · Class A
- Centurion — Centurion Medical Products · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- BBL™ CultureSwab™ Plus — COPAN ITALIA SPA · Class I
- Transystem™ — COPAN ITALIA SPA · Class I
- UTM® — COPAN ITALIA SPA · Class I
- Centurion — Centurion Medical Products · Class I
- Probówki o poj. 11ml, z MEDOPLASTU, z granulatem do szybkiego wykrzepiania, z nalepką — MEDLAB-PRODUCTS Sp. z o.o. · Class A
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 80533260BD0310AM0047B | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Copan Italia S.P.A.
- EUDAMED SRN
- IT-MF-000022535
Sources (1)
- EUDAMED 9494a936-5adb-4af7-b872-459484f63afe 61 fields · synced Jun 18, 2026