Identity
- Trade Name
- DNA/RNA Shield Saliva Collection Kit - DX EUDAMED
- Device Name
- DNA/RNA Shield Collection Tube w/ Swab - DX EUDAMED
- Model / Reference
- R1210-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027600109 EUDAMED
- Basic UDI-DI
- 08500276000709F2 EUDAMED
- EMDN Code
- W05019002,W05019003 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
DNA/RNA Shield Saliva Collection Kit - DX by Zymo Research Corp. — 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 | 08500276000709F2 | Class A | Active |
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Manufacturer
- Manufacturer
- Zymo Research Corp.
- EUDAMED SRN
- US-MF-000019308
- Authorised Representative
- DAVID Catherine Elisabeth Marie FR-AR-000006724
Sources (1)
- EUDAMED 884b88fd-0d5f-4f2a-bb7b-7bba5ad0b605 61 fields · synced Jul 8, 2026