← Back to catalogue
BREISKY Spekulum 100 x 35 mm
EUDAMEDClass I (EU MDR)
Ref 70-3100-35Model Spekulum, vaginal
Identity
- Trade Name
- BREISKY Spekulum 100 x 35 mm EUDAMED
- Model / Reference
- Spekulum, vaginal EUDAMED70-3100-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250379922083 EUDAMED
- Basic UDI-DI
- 42504853000002982D EUDAMED
- Direct Marketing DI
- 04250379922083 EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
BREISKY Spekulum 100 x 35 mm by Zepf Medical Instruments GmbH — 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 | 42504853000002982D | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zepf Medical Instruments GmbH
- EUDAMED SRN
- DE-MF-000005528
Sources (1)
- EUDAMED 0111e8d7-fcd8-4f0f-b2cb-4f81f2331d8e 61 fields · synced Sep 30, 2026