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MyoSimple Small Size

by Biotech Dental Smilers

Ref MyoSimple Petit

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37700200MYOSIMPLEKY Basic UDI-DI 03770020010255UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03770020010255 UDI-DI Date26 Mar 2026ListedStatusListed 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  • Withdrawn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
MyoSimple Petit EUDAMED
MyoSimple GUDID
Generic Name
Orthodontic retainer
Model / Reference
MyoSimple Petit EUDAMED
MyoSimple Small Size GUDID
Primary DI / UDI-DI
03770020010255
Basic UDI-DI
37700200MYOSIMPLEKY
Direct Marketing DI
03770020010255
FDA Product Code
KMY
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic retainer
Device Class
Class I
Regulation Number
872.5525
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MyoSimple Petit
GUDID
MyoSimple Small Size

Other devices from Biotech Dental Smilers

See all devices from Biotech Dental Smilers →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No