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Saliva RNA Collection and Preservation Devices Dx
EUDAMEDClass A (EU MDR)
Ref 53800
Identity
- Device Name
- Saliva RNA Collection and Preservation Devices Dx EUDAMED
- Model / Reference
- 53800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G226538000/ EUDAMED
- Basic UDI-DI
- ++G226SalivaRNACPdevXA EUDAMED
- Direct Marketing DI
- ++G226538000/ EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva RNA Collection and Preservation Devices Dx by Norgen Biotek Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Collection & Preservation
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 | ++G226SalivaRNACPdevXA | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Norgen Biotek Corporation
- EUDAMED SRN
- CA-MF-000024034
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED bee70c91-41d1-405f-9900-60e87be4bd23 61 fields · synced Jul 9, 2026