Identity
- Trade Name
- Sonosafe Probe Cover 28mm EUDAMED
- Device Name
- Non Sterile Natural Latex Probe Cover EUDAMED
- Model / Reference
- QA-280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 29556807393951 EUDAMED
- Basic UDI-DI
- 9556807PC001YP EUDAMED
- Direct Marketing DI
- 29556807393951 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Sonosafe Probe Cover 28mm by Richter Rubber Technology Sdn. Bhd. — 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 | 9556807PC001YP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Richter Rubber Technology Sdn Bhd
- EUDAMED SRN
- MY-MF-000023324
- Authorised Representative
- rrt Vertrieb und Service GmbH DE-AR-000021443
Sources (1)
- EUDAMED 9d8ac7c7-8432-4e71-bf92-ab0a720e652c 61 fields · synced Jun 17, 2026