Identity
- Trade Name
- H4™ EUDAMEDH4 FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- H4™ Self-Ligating (SL) Bracket System EUDAMEDH4 .022 NHK CASE FDA UDI
- Model / Reference
- H4 .022 NHK CASE EUDAMED916.2034 EUDAMEDFDA UDI
- Description
- H4 .022 NHK CASE FDA UDI
Identifiers
- Catalog Number
- 916.2034 FDA UDI
- Primary DI / UDI-DI
- 00840273920939 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840273920939 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
H4™ by World Class Technology Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840273920939 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- World Class Technology Corporation
- EUDAMED SRN
- US-MF-000014389
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 76f0e813-e612-491e-8070-1dd01d73d3aa 61 fields · synced Jun 18, 2026
- FDA UDI 4dcb47fa-a185-4b9d-9c2b-44153229a094 35 fields · synced May 29, 2026