Identity
- Device Name
- Speculum Kristeller 90x36 mm EUDAMED
- Model / Reference
- ES160-412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05407010685404 EUDAMED
- Basic UDI-DI
- B-05407010685404 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
Speculum Kristeller 90x36 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-05407010685404 | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Instruments Belgium
- EUDAMED SRN
- BE-MF-000029624
Sources (1)
- EUDAMED dc1d9f91-f8cc-4198-ac38-489b8b81fc6a 61 fields · synced Jun 19, 2026