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Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rect…
EUDAMEDClass I (EU MDR)
Ref 5-70340 KIT
Identity
- Device Name
- Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled EUDAMED
- Model / Reference
- 5-70340 KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5-70340KITSHEATHESCQ EUDAMED
- Basic UDI-DI
- B-5-70340KITSHEATHESCQ 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, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rect… 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-5-70340KITSHEATHESCQ | 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 de74c0cc-a935-4617-817a-ec7441df7a03 61 fields · synced Oct 6, 2026