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DNA/RNA Shield Collection Tube - 100 pack
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref N1082-EModel R1102-E
Identity
- Trade Name
- DNA/RNA Shield Collection Tube - 100 pack EUDAMED
- Device Name
- DNA/RNA Shield Collection Tube EUDAMED
- Model / Reference
- R1102-E EUDAMEDN1082-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027600390 EUDAMED
- Basic UDI-DI
- 0850027600R1102F6 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
DNA/RNA Shield Collection Tube - 100 pack by Zymo Research Corp. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202641 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0850027600R1102F6 | 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 (2)
- EUDAMED 4b604ed5-30b9-4661-96e4-2d334764dc35 61 fields · synced Jul 23, 2026
- FDA 510(k) K202641 1 fields · synced May 18, 2026