Identity
- Trade Name
- Pitts21™ EUDAMED
- Device Name
- Pitts21™ Self-Ligating Bracket System EUDAMED
- Model / Reference
- P21 7X7 U/L HKS 345 KIT EUDAMED946.2150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840273900795 EUDAMED
- Basic UDI-DI
- B-00840273900795 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
Pitts21™ by World Class Technology Corporation — 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-00840273900795 | Class IIa | Active |
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Manufacturer
- Manufacturer
- World Class Technology Corporation
- EUDAMED SRN
- US-MF-000014389
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED fe33a504-4395-447f-9795-4389371d2061 61 fields · synced Jun 9, 2026