Identity
- Device Name
- SEMM Speculum 100x17-20 mm EUDAMED
- Model / Reference
- ES160-128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05407010684995 EUDAMED
- Basic UDI-DI
- B-05407010684995 EUDAMED
- EMDN Code
- L03140102 VAGINAL SPREADERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SEMM Speculum 100x17-20 mm by Surgical Instruments Belgium — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05407010684995 | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Instruments Belgium
- EUDAMED SRN
- BE-MF-000029624
Sources (1)
- EUDAMED f12e4ccd-94b5-4111-97e8-598838c65064 61 fields · synced Jul 10, 2026