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Oxygen Mask R01A02011F

by Well Lead Medical Co., Ltd 2 variants

Ref R01A02011FModel Non-Rebreath Mask with oxygen tubing

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

CE MDR

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/MDR EUDAMED Number69449327FR01A00JT Basic UDI-DI 06936881167881UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936881167881 UDI-DI Date18 Feb 2025ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Wellleaad Oxygen Mask EUDAMED
Oxygen Mask GUDID
Generic Name
Rebreathing oxygen face mask
Model / Reference
R01A02011F, Non-Rebreath Mask with oxygen tubing
Primary DI / UDI-DI
06936881167881
Basic UDI-DI
69449327FR01A00JT
FDA Product Code
BYG
EMDN Code
R03010201 Air/oxygen masks
GMDN Term
Rebreathing oxygen face mask
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5580
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
No
GUDID
Yes
Contains LatexEUDAMED
Yes
GUDID
No

Related devices

Category: Rebreathing oxygen face mask

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Contains Latex YesEUDAMEDNoGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No