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cf-DNA/cf-RNA Preservative Tubes Dx
EUDAMEDClass IVD General (EU MDR)
Ref Dx63950
Identity
- Device Name
- cf-DNA/cf-RNA Preservative Tubes Dx EUDAMED
- Model / Reference
- Dx63950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Dx639503A EUDAMED
- Basic UDI-DI
- B-Dx639503A EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
cf-DNA/cf-RNA Preservative Tubes Dx by Norgen Biotek Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-Dx639503A | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Norgen Biotek Corporation
- EUDAMED SRN
- CA-MF-000024034
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c6dbec09-9acc-41c3-8347-c94a98a1a4a4 61 fields · synced Aug 1, 2026