Identity
- Trade Name
- Manta EUDAMED
- Device Name
- Manta Automated Sample Prep Robot EUDAMED
- Model / Reference
- CBWM100-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18906193751004 EUDAMED
- Basic UDI-DI
- 890619375CBWM100-CAL EUDAMED
- Direct Marketing DI
- 18906193751004 EUDAMED
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Malta 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
Yes
EUDAMED
New Device
No
EUDAMED
Manta by Cambrian Biotech Private Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890619375CBWM100-CAL | Class A | Active |
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Manufacturer
- Manufacturer
- Cambrian Biotech Private Limited
- EUDAMED SRN
- IN-MF-000046319
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (1)
- EUDAMED 96a390ec-09b8-466c-8abb-db3d7518deac 61 fields · synced Jul 20, 2026