Identity
- Trade Name
- Myoma Screws EUDAMED
- Device Name
- Myoma Screws EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004821950 EUDAMED
- Basic UDI-DI
- 89640048210968P EUDAMED
- EMDN Code
- L149001 ENT CURETTES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Myoma Screws by Burhan Kamran Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 89640048210968P | 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 1b5c875e-b77e-40b8-9d69-1525909163cc 61 fields · synced Jul 25, 2026