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WoodyKnows BP2

by M&M Pure Air Systems LLC

Ref 3003Model BP1/BP2/BP3

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number850040983003A3 Basic UDI-DI 00850040983012UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850040983012 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  • Withdrawn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
Lumbar spine orthosis
Device Name
WoodyKnows Side-Sleeping Backpack
Model / Reference
BP1/BP2/BP3 EUDAMED
3003 EUDAMED
BP2 GUDID
Primary DI / UDI-DI
00850040983012
Basic UDI-DI
850040983003A3
FDA Product Code
MRI
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Lumbar spine orthosis
Device Class
Class I
Regulation Number
890.3490
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BP1/BP2/BP3
3003
GUDID
BP2

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