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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • Hain Lifescience GmbH

Data from EUDAMED, last updated May 23, 2026

GENERIC HIV-1 VIRAL LOAD VER 2.0

40490550300001105U6

1 reference

IVDR Class D
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class D
Manufacturer
Hain Lifescience GmbH

Device family identification

Device name
GENERIC HIV-1 VIRAL LOAD VER 2.0
Basic UDI-DI
40490550300001105U6
Issuing agency
GS1
Version date
Jun 4, 2025

Classification

Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class D
Status
On the market

Manufacturer

Manufacturer

Name
Hain Lifescience GmbH
SRN
DE-MF-000008606
Country
Germany
Email
Thomas.Krespach@bruker.com

Device characteristics

ReagentProfessional testing

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • W0105030107Hiv 1 - na reagents

References by status

Clinical investigations

Registered
No

Legacy certificates

Certificate number
V70 079456 0011
Type
refdata.certificate-ivdr-type.technical-documentation
Notified body
TÜV SÜD Product Service GmbH (0123)
Validity
Jan 28, 2025 → Jan 27, 2030

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01JWXJ501ZC7EAQ8NHQ0HF5GX4

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
TR001.2-192TR001.2-192040490550039071On the market