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DNA/RNA Shield SafeCollect Swab Collection Kit (2mL)
EUDAMEDClass A (EU MDR)
Ref R1161-HModel R1160-H
Identity
- Trade Name
- DNA/RNA Shield SafeCollect Swab Collection Kit (2mL) EUDAMED
- Device Name
- DNA/RNA Shield SafeCollect Swab Collection Kit EUDAMED
- Model / Reference
- R1160-H EUDAMEDR1161-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027600543 EUDAMED
- Basic UDI-DI
- 0850027600R1160UDL EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
DNA/RNA Shield SafeCollect Swab Collection Kit (2mL) 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 | 0850027600R1160UDL | Class A | Active |
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Manufacturer
- Manufacturer
- Zymo Research Corp.
- EUDAMED SRN
- US-MF-000019308
- Authorised Representative
- BIOTIKA FR-AR-000045231
Sources (1)
- EUDAMED b8fb27c2-c24e-4002-90b6-f05ca02aed8a 61 fields · synced Jun 18, 2026