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Ultrasound Paper 84mm x 13.5m (Standard, Type I) Skymed
EUDAMEDClass I (EU MDR)
Ref SM84SModel SKYMEDRef SM84S(A)
Identity
- Trade Name
- Ultrasound Paper 84mm x 13.5m (Standard, Type I) Skymed EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSM84S EUDAMEDSM84S(A) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812500 EUDAMED09551019816201 EUDAMED
- Basic UDI-DI
- 955101981USP-SMMK EUDAMED
- Direct Marketing DI
- 09551019812500 EUDAMED09551019816201 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 84mm x 13.5m (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 (3)
- EUDAMED e1202d2c-3221-4a85-9c9c-45ace93bbf5a 61 fields · synced Oct 7, 2026
- EUDAMED 2ea0db19-6af5-4549-8c15-605494665679 61 fields · synced Jun 18, 2026
- EUDAMED 974bce46-3b85-47bb-9d62-906a7ac88d17 61 fields · synced Jul 27, 2026