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Ultrasound Paper 210mm x 25m (Standard, Type I) Skymed
EUDAMEDClass I (EU MDR)
Ref SM210SModel SKYMEDRef SM210S(A)
Identity
- Trade Name
- Ultrasound Paper 210mm x 25m (Standard, Type I) Skymed EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSM210S EUDAMEDSM210S(A) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812562 EUDAMED09551019816232 EUDAMED
- Basic UDI-DI
- 955101981USP-SMMK EUDAMED
- Direct Marketing DI
- 09551019812562 EUDAMED09551019816232 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 210mm x 25m (Standard, Type I) Skymed 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 b35ce4f2-68c5-4356-8bd2-52968cdee2a8 61 fields · synced Oct 6, 2026
- EUDAMED a2a5f7f2-4fe8-4de5-82d0-207c92813005 61 fields · synced Jul 14, 2026