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Kristeller Vaginal Specula, Fig.3 110 X 36mm
EUDAMEDClass I (EU MDR)
Ref DF-292-3365
Identity
- Trade Name
- Kristeller Vaginal Specula, Fig.3 110 X 36mm EUDAMED
- Device Name
- Non-Sterile, Reusable;Vaginal Specula EUDAMED
- Model / Reference
- DF-292-3365 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B974DF292336501* 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
Kristeller Vaginal Specula, Fig.3 110 X 36mm 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 71c20907-8bcd-4b9b-a3df-2a25aa50ebd5 61 fields · synced Jun 18, 2026