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Single Use Ent Specula's - Non - Sterile
EUDAMEDClass I (EU MDR)
Ref TE12-125Model Retractors - Non-Sterile
Identity
- Trade Name
- Thudicum Speculum No.2 EUDAMED
- Device Name
- SINGLE USE ENT SPECULA'S - NON - STERILE EUDAMED
- Model / Reference
- TE12-125 EUDAMEDRetractors - Non-Sterile EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417200191 EUDAMED
- Basic UDI-DI
- 506041720RETRACTOR-SUTE EUDAMED
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMEDQ030199 NASOPHARYNGEAL 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 c137ed35-d593-49ee-8fb3-8ec17360a384 61 fields · synced Jun 19, 2026
- EUDAMED 04bbe528-af6b-4f18-be3e-551d66a2739a 61 fields · synced Jun 19, 2026