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Trilogy™ Pretreatment Solution
EUDAMEDClass A (EU MDR)
Ref 922P-04Model 922P-0X Series
Identity
- Trade Name
- Trilogy™ Pretreatment Solution EUDAMED
- Device Name
- Trilogy™ Pretreatment Solution EUDAMED
- Model / Reference
- 922P-0X Series EUDAMED922P-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683116332 EUDAMED
- Basic UDI-DI
- 008416831922PUV EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Trilogy™ Pretreatment Solution by Cell Marque Corporation — 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 | 008416831922PUV | Class A | Active |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6c64a4f8-44ea-46b1-a991-f1cf4a82a6c0 61 fields · synced Aug 3, 2026