Identity
- Trade Name
- SEmm VAGINAL SPECULUM 100X25-30mm EUDAMED
- Device Name
- Non-Sterile, Reusable;Vaginal Specula EUDAMED
- Model / Reference
- DF-290-3348 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B974DF290334800* 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
SEmm VAGINAL SPECULUM 100X25-30mm by Dr.frigz International(pvt)ltd, — 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 | ++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 212e5a57-8643-4c7c-8fc1-3c229e542811 61 fields · synced Oct 6, 2026