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MagaBio plus Virus RNA Purification Kit Ⅱ

by Hangzhou Bioer Technology Co., Ltd. 9 variants

Ref BSC87L1EModel BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number697384322BSC87JB Basic UDI-DI 06973843227962UDI-DIDate9 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06973843227962 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MagaBio plus Virus RNA Purification Kit Ⅱ EUDAMED
BIOER MagaBio plus Virus RNA Purification Kit II GUDID
Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Reference
BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P
Primary DI / UDI-DI
06973843227962 EUDAMED
06973843228587 GUDID
Basic UDI-DI
697384322BSC87JB
Direct Marketing DI
06973843227962
FDA Product Code
JJH
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2310
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06973843227962
GUDID
06973843228587
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000019512
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Hangzhou Bioer Technology Co., Ltd.

See all devices from Hangzhou Bioer Technology Co., Ltd. →

Properties

  • Reagent
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Manufacturing Date: No