Identity
- Trade Name
- MolYsis-SNplus™ IVD EUDAMED
- Device Name
- MolYsis-SNplus™ IVD EUDAMED
- Model / Reference
- U-300-012 EUDAMEDU-300-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262473060004 EUDAMED04262473060028 EUDAMED
- Basic UDI-DI
- 426247306U-300WF 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
Yes
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
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
MolYsis-SNplus™ IVD by Molzym GmbH & Co.KG — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | 426247306U-300WF | Class A | Active |
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Manufacturer
- Manufacturer
- Molzym GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000037419
Sources (2)
- EUDAMED 69f7b2fc-6c4f-45c8-9854-c70b149df93d 61 fields · synced Jul 21, 2026
- EUDAMED 2bce1235-2be8-4168-b2cd-3d324e82d1ea 61 fields · synced May 18, 2026