Identity
- Trade Name
- SEmm VAGINAL SPECULUM 90X14-18mm EUDAMED
- Device Name
- Non-Sterile, Reusable;Vaginal Specula EUDAMED
- Model / Reference
- DF-290-3347A EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B974DF2903347A09* EUDAMED
- Basic UDI-DI
- ++B974SpeculaCC 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
Category: Vaginal speculum, reusable
SEmm VAGINAL SPECULUM 90X14-18mm by Dr.frigz International(pvt)ltd, — Class I — MDR — listed in EUDAMED — 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 | ++B974SpeculaCC | Class I | Active |
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Manufacturer
- Manufacturer
- Dr. Frigz International (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000009661
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED f2bad168-635b-4e90-b486-7b8647ad2432 61 fields · synced Oct 6, 2026