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Ultrasound Paper Type II (High Density)
EUDAMEDClass I (EU MDR)
Ref ACC-110HDModel Accu-Plus
Identity
- Trade Name
- Ultrasound Paper Type II (High Density) EUDAMEDUltrasound Paper 110mm x 20m (High Density, Type II) ACCU-PLUS EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-110HD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810667 EUDAMED
- Basic UDI-DI
- 955101981USP-APL3 EUDAMED
- Direct Marketing DI
- 09551019810667 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-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 (2)
- EUDAMED 7dac4ff5-7302-4d5c-9bf3-a74c81a315af 61 fields · synced Jul 17, 2026
- EUDAMED 426ace89-84a2-4ce8-8869-1e3f121ac41c 61 fields · synced Jul 17, 2026