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Orthodontic Lingual Cleats

EUDAMED

Class IIa (EU MDR)

Ref 4240-00Ref 4250-01Ref 4250-00Ref 4530-00

by Astar Orthodontics Inc.

Identity

Device Name
Orthodontic Lingual Cleats EUDAMED
Model / Reference
4240-00 EUDAMED
4250-01 EUDAMED
4250-00 EUDAMED
4530-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06973329326349 EUDAMED
06973329326394 EUDAMED
06941673545075 EUDAMED
06973329326615 EUDAMED
Basic UDI-DI
697332932CLT2932ML EUDAMED
69416735CLT735NP EUDAMED
Direct Marketing DI
06973329326349 EUDAMED
06973329326394 EUDAMED
06941673545075 EUDAMED
06973329326615 EUDAMED
EMDN Code
Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Portugal EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Orthodontic Lingual Cleats by Astar Orthodontics Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Astar Orthodontics Inc.
EUDAMED SRN
CN-MF-000028647
Authorised Representative
BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480

Sources (4)

  • EUDAMED 180ad02c-bba7-42f2-ac3d-852d59ea1618 61 fields · synced Jul 30, 2026
  • EUDAMED 97510140-f08e-40e5-8eaf-f95c954a9ab9 61 fields · synced May 17, 2026
  • EUDAMED 0aad824b-aa5a-4dc9-8a33-c11fdad02a33 61 fields · synced May 18, 2026
  • EUDAMED 5d4a38a5-0d8a-48a0-9162-8bdbfbf7e782 61 fields · synced May 19, 2026