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Promotor Nucleic Acid (RNA) Extraction Kit
EUDAMEDClass A (EU MDR)
Ref P121-1121-201Ref P121-1221-201Ref P121-1221-202
Identity
- Trade Name
- Promotor Nucleic Acid (RNA) Extraction Kit EUDAMED
- Device Name
- Nucleic Acid (RNA) Extraction Kit EUDAMED
- Model / Reference
- P121-1121-201 EUDAMEDP121-1221-201 EUDAMEDP121-1221-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921756492090 EUDAMED06921756492106 EUDAMED06921756492113 EUDAMED
- Basic UDI-DI
- 6921756499990014WY EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Category: Nucleic acid extraction/isolation kit IVD
Promotor Nucleic Acid (RNA) Extraction Kit by Acon Biotech (Hangzhou) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 6921756499990014WY | Class A | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 43f06eeb-3d2e-4eff-af74-e6261d7a51cb 61 fields · synced Jul 15, 2026
- EUDAMED 925116c8-c5d5-4faf-92a0-dc6cd768be0e 61 fields · synced May 17, 2026
- EUDAMED be79dbd8-c1c5-49a9-81a3-e151eecefa8e 61 fields · synced May 18, 2026