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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
  • SINGLERA GENOMICS (JIANGSU) LTD.

Data from EUDAMED, last updated Jun 11, 2026

Nucleic Acid Purification System

697597065INST04ZN

1 reference

IVDR Class A
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class A
Manufacturer
SINGLERA GENOMICS (JIANGSU) LTD.

Device family identification

Device name
Nucleic Acid Purification System
Basic UDI-DI
697597065INST04ZN
Device model
NAE24 PIus
Issuing agency
GS1
Version date
Apr 13, 2026

Classification

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

Manufacturer & authorised representative

Manufacturer

Name
SINGLERA GENOMICS (JIANGSU) LTD.
SRN
CN-MF-000033428
Country
China
Email
RA@singleragenomics.com

Authorised representative

Name
SUNGO Europe B.V.
SRN
NL-AR-000000247
Country
Netherlands

Device characteristics

Professional testing

EMDN code(s)

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

  • W02050106Dna genomic preparation devices

References by status

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KP29Q7PZZAF7Y61F4YFF2A6D

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
Nucleic Acid Purification SystemINST040024CE069759706500261On the market