Identity
- Trade Name
- Ultrashcallsondenabdeckung EUDAMED
- Device Name
- Sterile Extended Field Ultrasound Probe Cover EUDAMED
- Model / Reference
- 5-961 KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842418103436 EUDAMED
- Basic UDI-DI
- 08424181C2PSEX 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultrashcallsondenabdeckung by Sheathing Technologies, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08424181C2PSEX | 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 262e0748-f5f3-40aa-9047-fa5017b3172d 61 fields · synced Sep 17, 2026