Identity
- Trade Name
- Kristeller Vaginal Speculum Large EUDAMED
- Device Name
- Kristeller Vaginal Speculum Large EUDAMED
- Model / Reference
- M15-037-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G410M15037030 EUDAMED
- Basic UDI-DI
- ++G410M1503703SS EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Kristeller Vaginal Speculum Large by Mehrish Industries 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 | ++G410M1503703SS | Class I | Active |
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Manufacturer
- Manufacturer
- Mehrish Industries Pvt Ltd
- EUDAMED SRN
- PK-MF-000031501
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED f756cc4f-9f65-445a-95a8-7f5f21db6bd0 61 fields · synced Jun 20, 2026