Identity
- Trade Name
- Ent/Dissecting/Lighting Instruments EUDAMED
- Device Name
- ENT/Dissecting/ Lighting Instruments EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004821905 EUDAMED
- Basic UDI-DI
- 89640048210928F EUDAMED
- EMDN Code
- L149011 ENT SURGERY DISSECTORS, 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
Category: Open-surgery dissector
Ent/Dissecting/Lighting Instruments 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 | 89640048210928F | 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 0162941a-6c01-4a66-9a40-fc5cebee6816 61 fields · synced Jul 21, 2026