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Ultrasound Paper 84mm x 13.5m (Standard, Type I) Alpha-Plus
EUDAMEDClass I (EU MDR)
Ref APP84SModel ALPHA-PLUS
Identity
- Trade Name
- Ultrasound Paper 84mm x 13.5m (Standard, Type I) Alpha-Plus EUDAMED
- Device Name
- Ultrasound paper EUDAMED
- Model / Reference
- ALPHA-PLUS EUDAMEDAPP84S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019817017 EUDAMED
- Basic UDI-DI
- 955101981USPAPLQ EUDAMED
- Direct Marketing DI
- 09551019817017 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
Yes
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) Alpha-Plus 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 | 955101981USPAPLQ | 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 (1)
- EUDAMED 43a22544-c3e5-4686-81b5-35d159d8096a 61 fields · synced Jun 19, 2026