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WoodyKnows ND2

by M&M Pure Air Systems LLC

Ref 3001Model ND1/ND2/ND3/ND4

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8500409830019X Basic UDI-DI 00850040983128UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850040983128 UDI-DI Date19 May 2026ListedStatusListed GUDID: not 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  • Withdrawn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
WoodyKnows
Generic Name
Nasal breathing aid, internal, reusable
Device Name
WoodyKnows Nasal Dilators
Model / Reference
ND1/ND2/ND3/ND4 EUDAMED
3001 EUDAMED
ND2 GUDID
Primary DI / UDI-DI
00850040983128
Basic UDI-DI
8500409830019X
FDA Product Code
LWF
EMDN Code
R050299 Respiratory dilation systems - other
GMDN Term
Nasal breathing aid, internal, reusable
Device Class
Class I
Regulation Number
874.3900
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ND1/ND2/ND3/ND4
3001
GUDID
ND2

Other devices from M&M Pure Air Systems LLC

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No