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Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2…
EUDAMEDClass IIa (EU MDR)
Ref 5-365 KIT
Identity
- Device Name
- Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled EUDAMED
- Model / Reference
- 5-365 KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5-365KITSHEATHESQE EUDAMED
- Basic UDI-DI
- B-5-365KITSHEATHESQE EUDAMED
- EMDN Code
- T030199,Z11040185 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2… by Sheathing Technologies, Inc. — Class IIa — 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-5-365KITSHEATHESQE | Class IIa | 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 3f33bafa-b466-4474-9264-c777f6dd7e87 61 fields · synced Jun 18, 2026