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Ultrasound Paper 84mm x 13.5m (Standard, Type I) ACCU-PLUS
EUDAMEDClass I (EU MDR)
Ref ACC-84SModel Accu-PlusRef ACC-84S(A)Ref APP84S(A)Model ALPHA-PLUS
Identity
- Trade Name
- Ultrasound Paper 84mm x 13.5m (Standard, Type I) ACCU-PLUS EUDAMEDUltrasound Paper 84mm x 13.5m (Standard, Type I) Alpha-Plus EUDAMED
- Device Name
- Ultrasound Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-84S EUDAMEDACC-84S(A) EUDAMEDALPHA-PLUS EUDAMEDAPP84S(A) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812623 EUDAMED09551019816294 EUDAMED09551019817109 EUDAMED
- Basic UDI-DI
- 955101981USP-APL3 EUDAMED955101981USPAPLQ EUDAMED
- Direct Marketing DI
- 09551019812623 EUDAMED09551019816294 EUDAMED09551019817109 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) ACCU-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 | 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 (4)
- EUDAMED b419dc26-f5b4-4b4c-9709-70c368260c2b 61 fields · synced Oct 5, 2026
- EUDAMED f43943b2-98eb-4f97-86df-cbc76da23881 61 fields · synced Jul 13, 2026
- EUDAMED f3e07a29-eba4-4efc-bfa8-14878c569ee8 61 fields · synced Jul 28, 2026
- EUDAMED 32970bcf-a0d9-4408-8d22-7641dfef5bd2 61 fields · synced Oct 5, 2026