Identity
- Trade Name
- SIMS UTERINE SOUNDS 32CM EUDAMED
- Device Name
- SIMS UTERINE SOUNDS 32CM EUDAMED
- Model / Reference
- 61-390 RI EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G26861390RI2A EUDAMED
- Basic UDI-DI
- B-++G26861390RI2A EUDAMED
- EMDN Code
- L059008 OBSTETRIC AND GYNECOLOGICAL SURGERY INSTRUMENT KITS, 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
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
Sims Uterine Sounds 32cm by Raydent 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-++G26861390RI2A | Class I | Active |
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Manufacturer
- Manufacturer
- Raydent Instruments
- EUDAMED SRN
- PK-MF-000032781
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED aa3b60f7-03ae-4bf0-8783-3a9023fff9d5 61 fields · synced Jul 18, 2026