Identity
- Device Name
- Matrix Retainers EUDAMED
- Model / Reference
- 36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004821554 EUDAMED
- Basic UDI-DI
- 89640048210568B EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Dental appliance fabrication material, ceramic
Matrix Retainers by Burhan Kamran Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 89640048210568B | Class I | Active |
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Manufacturer
- Manufacturer
- Burhan Kamran Industries
- EUDAMED SRN
- PK-MF-000052581
- Authorised Representative
- EU-UK AUTHORISED REPRESENTATIVE LIMITED XI-AR-000047163
Sources (1)
- EUDAMED 8bcfbe90-2e13-4bcf-b97b-7ba33bc9fb61 61 fields · synced Jul 15, 2026