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Single Use Ent Specula's - Non - Sterile
EUDAMEDClass I (EU MDR)
Ref TE10-138Model Retractors - Non-Sterile
Identity
- Trade Name
- Gruber Aural Specula 6mm EUDAMED
- Device Name
- SINGLE USE ENT SPECULA'S - NON - STERILE EUDAMED
- Model / Reference
- TE10-138 EUDAMEDRetractors - Non-Sterile EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417200108 EUDAMED
- Basic UDI-DI
- 506041720RETRACTOR-SUTE EUDAMED
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMEDQ030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Single Use Ent Specula's - Non - Sterile 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-SUTE | Class I | Active |
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Manufacturer
- Manufacturer
- Sheffmed Limited
- EUDAMED SRN
- GB-MF-000004158
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 18b5c97b-f069-4dab-a78b-591ea0a3057b 61 fields · synced Jun 18, 2026
- EUDAMED 846680b0-ff3f-4cb6-ba22-629a496ab3db 61 fields · synced Jun 18, 2026