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Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Strai…
EUDAMEDClass I (EU MDR)
Ref 10340 (ITL)
Identity
- Device Name
- Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long EUDAMED
- Model / Reference
- 10340 (ITL) EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-10340(ITL)SHEATHESXD EUDAMED
- Basic UDI-DI
- B-10340(ITL)SHEATHESXD EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Strai… by Sheathing Technologies, Inc. — Class I — MDD — listed in EUDAMED
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-10340(ITL)SHEATHESXD | Class I | Active |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
- EUDAMED SRN
- US-MF-000044559
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 55a542bd-ac6a-42a2-aa28-7fc00e6e3a88 61 fields · synced Jun 18, 2026