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System Ii Hex - Cassette - Dark Blue (loose Bagged)
EUDAMEDClass A (EU MDR)
Ref EAD-0116-03BRef EAD-0116-03A
by CellPath Ltd
Identity
- Trade Name
- SYSTEM II HEX - CASSETTE - DARK BLUE (LOOSE BAGGED) EUDAMEDSYSTEM II HEX - CASSETTE - DARK BLUE (LOOSE) EUDAMED
- Device Name
- SYSTEM II HEX EUDAMED
- Model / Reference
- EAD-0116-03B EUDAMEDEAD-0116-03A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056256104974 EUDAMED05056256114652 EUDAMED
- Basic UDI-DI
- 05056256EAD001WP 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
Yes
EUDAMED
New Device
Yes
EUDAMED
System Ii Hex - Cassette - Dark Blue (loose Bagged) 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 | 05056256EAD001WP | 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 (2)
- EUDAMED cd050c93-aea6-442e-8bba-c77b92c21422 61 fields · synced Jul 18, 2026
- EUDAMED 03464869-b5d7-4ada-b625-039c9190f35b 61 fields · synced May 17, 2026