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Breisky vaginal speculum +1 more model
EUDAMEDClass I (EU MDR)
Ref 397122910154
by MEDIN, a.s.
Identity
- Trade Name
- Breisky vaginal speculum; 130×20 mm EUDAMED
- Device Name
- Vaginal speculum EUDAMED
- Model / Reference
- 397122910154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712123399 EUDAMED
- Basic UDI-DI
- 85917125100101UM EUDAMED
- Direct Marketing DI
- 08591712123399 EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
- Models / Variants
- Breisky vaginal speculum EUDAMED130×20 mm EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Breisky vaginal speculum +1 more model by MEDIN, a.s. — Class I — MDR — listed in EUDAMED — 2 models — 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 | 85917125100101UM | Class I | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (1)
- EUDAMED f90a963f-3bed-4425-84ef-904c4f82bae0 61 fields · synced Jun 18, 2026