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Single Use Ent Specula's - Non - Sterile
EUDAMEDClass I (EU MDR)
Ref P60-503Model Retractors - Non-Sterile
Identity
- Trade Name
- Shea Aural Specula 6mm PK 100 EUDAMED
- Device Name
- SINGLE USE ENT SPECULA'S - NON - STERILE EUDAMED
- Model / Reference
- P60-503 EUDAMEDRetractors - Non-Sterile EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417202775 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 62405a2f-279f-4614-b7fb-6ded9b368a9d 61 fields · synced Jul 17, 2026
- EUDAMED 3ca9c3a2-a0e2-40c3-a7e1-4843be74a94e 61 fields · synced Jul 17, 2026