← Back to catalogue
chest suction ball
EUDAMEDClass I (EU MDR)
Ref AMD-SE-PM0001-1Model AMD-SE/LERef AMD-SE-AB0002-2Ref AMD-SE-PB0001-1Ref AMD-SE-PM0002-2
Identity
- Trade Name
- chest suction ball EUDAMED
- Device Name
- ECG electrodes EUDAMED
- Model / Reference
- AMD-SE/LE EUDAMEDAMD-SE-PM0001-1 EUDAMEDAMD-SE-AB0002-2 EUDAMEDAMD-SE-PB0001-1 EUDAMEDAMD-SE-PM0002-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931377230940 EUDAMED06931377231060 EUDAMED06931377230872 EUDAMED06931377230988 EUDAMED
- Basic UDI-DI
- 69313772807UW EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Category: General-purpose multi-parameter bedside monitor
chest suction ball by Shenzhen Amydi-med Electrics Tech Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose multi-parameter bedside monitor.
- SpO2 Adapter cable — Orantech Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
- Expression MR200 Accessories — Philips DS North America LLC · Class II
- IBP Adapter Cable — Orantech Inc. · Class I
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
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 | 69313772807UW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Amydi-med Electrics Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000013201
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED 8cb54387-a66d-4dc6-8640-d2d0f114b32d 61 fields · synced Oct 6, 2026
- EUDAMED 88d47d63-e5c2-4182-bd6a-00a66c61e0d2 61 fields · synced May 17, 2026
- EUDAMED 3dc1b708-202a-481c-b87d-ce5d8e40f949 61 fields · synced May 18, 2026
- EUDAMED a219f5ca-7ada-40f2-b75e-905ec3d8110e 61 fields · synced May 19, 2026