Identity
- Trade Name
- Prostate Kit EUDAMED
- Device Name
- Receptacles EUDAMED
- Model / Reference
- 3800852 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849832023050 EUDAMED
- Basic UDI-DI
- 849832004UM EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prostate Kit by Leica Biosystems Richmond, Inc. — 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 | 849832004UM | Class A | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Richmond, Inc
- EUDAMED SRN
- US-MF-000014614
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 820b8186-1a21-446d-89ce-120d7f550cb7 61 fields · synced Jul 22, 2026