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Hartmann Aural Speculum 3.5mm
EUDAMEDClass I (EU MDR)
Ref E10-149Model Retractors - Reusable
Identity
- Trade Name
- Hartmann Aural Speculum 3.5mm EUDAMED
- Model / Reference
- Retractors - Reusable EUDAMEDE10-149 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417203475 EUDAMED
- Basic UDI-DI
- 506041720RETRACTOR-RUTB EUDAMED
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Hartmann Aural Speculum 3.5mm by Sheffmed Limited — 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 | 506041720RETRACTOR-RUTB | Class I | Active |
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Manufacturer
- Manufacturer
- Sheffmed Limited
- EUDAMED SRN
- GB-MF-000004158
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 325d686a-0b8f-4298-90b5-1a4a0b93b9ff 61 fields · synced Jul 9, 2026