← Back to catalogue
Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, R…
EUDAMEDClass I (EU MDR)
Ref 5-80340 KIT
Identity
- Device Name
- Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Rolled EUDAMED
- Model / Reference
- 5-80340 KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5-80340KITSHEATHESED EUDAMED
- Basic UDI-DI
- B-5-80340KITSHEATHESED EUDAMED
- EMDN Code
- T030199,Z11040185 EUDAMED
Classification
- Device Class
- Class I 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, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, R… 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-5-80340KITSHEATHESED | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
- EUDAMED SRN
- US-MF-000044559
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 004f68df-5250-44f5-a68b-07ed5e00bb01 61 fields · synced Oct 6, 2026