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Ultrasound Paper Type V (High Glossy)
EUDAMEDClass I (EU MDR)
Ref SM110HGModel SKYMED
Identity
- Trade Name
- Ultrasound Paper Type V (High Glossy) EUDAMEDUltrasound Paper 110mm x 18m (High Glossy, Type V) Skymed EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSM110HG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810193 EUDAMED
- Basic UDI-DI
- 955101981USP-SMMK EUDAMED
- Direct Marketing DI
- 09551019810193 EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
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
Ultrasound Paper Type V (High Glossy) by Isd Meditech Sdn. Bhd. — Class I — 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 | 955101981USP-SMMK | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ea851a15-ef39-4465-8ade-45f3e6acdd57 61 fields · synced Jun 18, 2026
- EUDAMED c62c51c4-7c52-48b2-bc19-293280d1d7a6 61 fields · synced Jun 18, 2026