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Ultrasound Probe Cover 15 × 84 cm
EUDAMEDClass I (EU MDR)
Ref 2507Model TF-1011Ref JAD01Model TF1011Ref PS9050NS
Identity
- Trade Name
- Ultrasound Probe Cover 15 × 84 cm EUDAMEDUltrasound Probe Cover (Size 15 x 84cm) EUDAMEDUltrasound Probe Cover EUDAMED
- Device Name
- Ultrasound Probe Cover EUDAMEDULTRASOUND PROBE COVERS EUDAMED
- Model / Reference
- TF-1011 EUDAMED2507 EUDAMEDTF1011 EUDAMEDJAD01 EUDAMEDPS9050NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223011262 EUDAMEDD-050512230111946R EUDAMED05051223027188 EUDAMED
- Basic UDI-DI
- B-05051223011262 EUDAMEDB-050512230111946R EUDAMED50512230ULTRASOUNDPC4G EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Ultrasound Probe Cover 15 × 84 cm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05051223011262 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05051223011262 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 77611566-4647-4389-8bf2-8ff461ee8ad6 61 fields · synced Oct 6, 2026
- EUDAMED 760cbd87-01fb-4cbb-bf44-cbfd08ff1edb 61 fields · synced May 17, 2026
- EUDAMED 7df54b8b-b547-4385-8151-2cd32279176f 61 fields · synced May 19, 2026