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Ultrasound Paper Type II (High Density)
EUDAMEDClass I (EU MDR)
Ref SM110HDModel SKYMED
Identity
- Trade Name
- Ultrasound Paper Type II (High Density) EUDAMEDUltrasound Paper 110mm x 20m (High Density, Type II) Skymed EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSM110HD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810209 EUDAMED
- Basic UDI-DI
- 955101981USP-SMMK EUDAMED
- Direct Marketing DI
- 09551019810209 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 II (High Density) 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 2a17dd3e-2da6-47f2-9f62-d7e3672d873d 61 fields · synced Jun 18, 2026
- EUDAMED c29e1c63-6792-40b5-a921-3a616b5db906 61 fields · synced Jun 18, 2026