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Breisky Vaginal Speculum 100x40 mm, 28 cm
EUDAMEDClass I (EU MDR)
Ref ES160-354
Identity
- Device Name
- Breisky Vaginal Speculum 100x40 mm, 28 cm EUDAMED
- Model / Reference
- ES160-354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05407010685329 EUDAMED
- Basic UDI-DI
- B-05407010685329 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
Breisky Vaginal Speculum 100x40 mm, 28 cm 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-05407010685329 | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Instruments Belgium
- EUDAMED SRN
- BE-MF-000029624
Sources (1)
- EUDAMED a49b8fce-a25c-4bf2-99e4-a8075d96b790 61 fields · synced Jul 12, 2026