Identity
- Trade Name
- EasyPure® Viral DNA/ RNA Kit EUDAMED
- Device Name
- EasyPure® Viral DNA/ RNA Kit EUDAMED
- Model / Reference
- ER201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975422630026 EUDAMED
- Basic UDI-DI
- 697542263ER201EB EUDAMED
- Direct Marketing DI
- 06975422630026 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
- Netherlands 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
EasyPure® Viral DNA/ RNA Kit by TransGen Biotech Co., Ltd — 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 | 697542263ER201EB | Class A | Active |
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Manufacturer
- Manufacturer
- TransGen Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000025790
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED bec20ee9-0f32-4a84-91d4-c608a219649e 61 fields · synced Jun 19, 2026