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Breisky vaginal speculum +1 more model
EUDAMEDClass I (EU MDR)
Ref 397122910155
by MEDIN, a.s.
Identity
- Trade Name
- Breisky vaginal speculum; 130×25 mm EUDAMED
- Device Name
- Vaginal speculum EUDAMED
- Model / Reference
- 397122910155 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712123405 EUDAMED
- Basic UDI-DI
- 85917125100101UM EUDAMED
- Direct Marketing DI
- 08591712123405 EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
- Models / Variants
- Breisky vaginal speculum EUDAMED130×25 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
Category: Vaginal speculum, reusable
Breisky vaginal speculum +1 more model by MEDIN, a.s. — Class I — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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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 5464786f-b73f-4cb0-a657-9dde49e45060 61 fields · synced Jun 19, 2026