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System Ii+ Round Cassette - Dark Blue (hoppered)
EUDAMEDClass A (EU MDR)
Ref EAM-0816-05H
by CellPath Ltd
Identity
- Trade Name
- SYSTEM II+ ROUND CASSETTE - DARK BLUE (HOPPERED) EUDAMED
- Device Name
- System II+ EUDAMED
- Model / Reference
- EAM-0816-05H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056256115710 EUDAMED
- Basic UDI-DI
- 05056256EAM002YQ EUDAMED
- EMDN Code
- W0202050385 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
System Ii+ Round Cassette - Dark Blue (hoppered) by CellPath Ltd — 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 | 05056256EAM002YQ | Class A | Active |
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Manufacturer
- Manufacturer
- CellPath Ltd
- EUDAMED SRN
- GB-MF-000022744
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 8707af0b-0871-4dc9-aa28-5f416241613b 61 fields · synced Jul 18, 2026