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Ultrasound Paper 84mm x 13.5m (High Density, Type II) ACCUPLUS
EUDAMEDClass I (EU MDR)
Ref ACC-84HDModel Accu-PlusRef SM84HDModel SKYMEDRef APP84HDModel ALPHA-PLUS
Identity
- Trade Name
- Ultrasound Paper 84mm x 13.5m (High Density, Type II) ACCUPLUS EUDAMEDUltrasound Paper 84mm x 13.5m (High Density, Type II) Skymed EUDAMEDUltrasound Paper 84mm x 13.5m (High Density, Type II) ACCU-PLUS EUDAMEDUltrasound Paper 84mm x 13.5m (High Density, Type II) Alpha-Plus EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-84HD EUDAMEDSKYMED EUDAMEDSM84HD EUDAMEDALPHA-PLUS EUDAMEDAPP84HD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812630 EUDAMED09551019812517 EUDAMED09551019816355 EUDAMED
- Basic UDI-DI
- 955101981USP-APL3 EUDAMED955101981USP-SMMK EUDAMED955101981USPAPLQ EUDAMED
- Direct Marketing DI
- 09551019812630 EUDAMED09551019812517 EUDAMED09551019816355 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 (High Density, Type II) ACCUPLUS 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-APL3 | 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 (5)
- EUDAMED 8dd6147d-24a2-46bf-9963-868f89c70120 61 fields · synced Oct 6, 2026
- EUDAMED b99232b3-4b4f-4684-91dd-be85ba92f4be 61 fields · synced May 19, 2026
- EUDAMED 01e65e7d-4b83-43ac-96d1-0fa68b53066c 61 fields · synced Jun 20, 2026
- EUDAMED a179ee8f-6b6b-43f6-9202-15e105820718 61 fields · synced Jul 13, 2026
- EUDAMED 4d82a51b-1c83-47c1-8f03-c004a6c0949c 61 fields · synced Jul 24, 2026