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Orthodontic Treatment Planning Software

by Shanghai EA Medical Instruments Co., Ltd.

Ref iOrtho

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223518↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977207040020 UDI-DI Date8 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697720704SOFTWARE001V6 Basic UDI-DI 06977207040020UDI-DIDate5 Jan 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK223518 Date13 Jun 2023IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Angel Aligner
Generic Name
CAD/CAM software
Device Name
Orthodontic Treatment Planning Software
Model / Reference
iOrtho
Primary DI / UDI-DI
06977207040020 EUDAMED
06977207040662 GUDID
Basic UDI-DI
697720704SOFTWARE001V6
FDA Product Code
PNN
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN Term
CAD/CAM software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.5470
Special Device Type
Software
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06977207040020
GUDID
06977207040662
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000040940
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai EA Medical Instruments Co., Ltd.

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Properties

Other properties (24)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No