Identity
- Trade Name
- Wrangler Instruments EUDAMED
- Device Name
- Speculum, vaginal, Graves, 115 x 35 mm EUDAMED
- Model / Reference
- 15-410-03UN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18964003896420 EUDAMED
- Basic UDI-DI
- B-18964003896420 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wrangler Instruments by Wrangler Instruments — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18964003896420 | Class I | Active |
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Manufacturer
- Manufacturer
- Wrangler Instruments
- EUDAMED SRN
- PK-MF-000009409
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED edf9dd18-29d8-4931-883c-7d03ebfade85 61 fields · synced Jun 19, 2026