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ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube
EUDAMEDClass I (EU MDR)
Ref ZCC4001HP-10Model Blood Pressure Cuffs
by Salter Labs
Identity
- Trade Name
- ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube EUDAMED
- Model / Reference
- Blood Pressure Cuffs EUDAMEDZCC4001HP-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411911825 EUDAMED
- Basic UDI-DI
- 0607411TF20000_BPCuffK6 EUDAMED
- Unit of Use DI
- 00607411911828 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube by Salter Labs — 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 | 0607411TF20000_BPCuffK6 | Class I | Active |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED e42d3275-0914-4254-b646-bcd7840ca779 61 fields · synced Jul 29, 2026