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Perfect Clear Ii
EUDAMEDClass IIa (EU MDR)
Ref 230-501Model 230-501 PERFECT CLEAR ∥ MBT022
Identity
- Trade Name
- PERFECT CLEAR II EUDAMED
- Model / Reference
- 230-501 PERFECT CLEAR ∥ MBT022 EUDAMED230-501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033423355 EUDAMED
- Basic UDI-DI
- B-08800033423355 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Perfect Clear Ii by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800033423355 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Osstem Orthodontics Inc.
- EUDAMED SRN
- KR-MF-000021559
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 204bd1b7-cf76-4eb7-836a-be96c9ab8b3f 61 fields · synced Jun 18, 2026