MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

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

Subscribe to our monthly newsletter:

  • MD Atlas
  • BioTeke Corporation(Wuxi)Co., Ltd

Data from EUDAMED, last updated Jun 11, 2026

Consumables for Nucleic Acid Extraction

697454156015L6

3 references

IVDR Class A
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class A
Manufacturer
BioTeke Corporation(Wuxi)Co., Ltd

Device family identification

Device name
Consumables for Nucleic Acid Extraction
Basic UDI-DI
697454156015L6
Device model
AU1001-2,AU1001-3,AU1001-5
Issuing agency
GS1
Version date
May 15, 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
BioTeke Corporation(Wuxi)Co., Ltd
SRN
CN-MF-000007517
Country
China
Email
info@bioteke.cn
Phone
+86 (0510)8332 3992

Authorised representative

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

Device characteristics

No device characteristics flagged

EMDN code(s)

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

  • W0599Ivd general use consumable devices - other

References by status

References

3 references

Export results

Applied filters

  • basicUdiUlid·01KRN7Q5G7SVE6W5WD08WDQG8H

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
AU1001-2AU1001-2069745415652331On the market
AU1001-5AU1001-5069745415652571On the market
AU1001-3AU1001-3069745415652401On the market