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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
  • Well Lead Medical Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

Oxygen Mask

69449327FR01A00JT

16 references

Class IIa
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Manufacturer
Well Lead Medical Co., Ltd.

Device family identification

Device name
Oxygen Mask
Basic UDI-DI
69449327FR01A00JT
Device model
Non-Rebreath Mask with oxygen tubing
Issuing agency
GS1
Version date
May 15, 2026

Classification

Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Well Lead Medical Co., Ltd.
SRN
CN-MF-000006728
Country
China
Email
jenny_zhu@welllead.com.cn

Authorised representative

Name
Shanghai International Holding Corp. GmbH(Europe)
SRN
DE-AR-000000001
Country
Germany
Phone
+49 40 2513175

Device characteristics

No device characteristics flagged

EMDN code(s)

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

  • R03010201Air/oxygen masks

References by status

References

16 references

Export results

Applied filters

  • basicUdiUlid·01KRN28W89VTX8DM6H61ASR1JY

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
Wellleaad Oxygen MaskR01A02048F069368811679591On the market
Wellleaad Oxygen MaskR01A02041F069449327661431On the market
Wellleaad Oxygen MaskR01A02048F069368811669691On the market
Wellleaad Oxygen MaskR01A02038F 069368811679351On the market
Wellleaad Oxygen MaskR01A02018F069368811679281On the market
Wellleaad Oxygen MaskR01A02021F069449327661051On the market
Wellleaad Oxygen MaskR01A02041F069368811679111On the market
Wellleaad Oxygen MaskR01A02021F069368811679041On the market
Wellleaad Oxygen MaskR01A02031F069449327661291On the market
Wellleaad Oxygen MaskR01A02038F 069368811669451On the market
Wellleaad Oxygen MaskR01A02031F069368811678981On the market
Wellleaad Oxygen MaskR01A02011F069368811678811On the market
Wellleaad Oxygen MaskR01A02028F069368811669521On the market
Wellleaad Oxygen MaskR01A02018F069368811669381On the market
Wellleaad Oxygen MaskR01A02028F069368811679421On the market
Welllead Oxygen MaskR01A02011F069449327660821On the market