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Examination Couch
EUDAMEDClass I (EU MDR)
Ref ECA16Model HL-A161A、HL-A161B、HL-A161C、HL-A162A、HL-A162B、HL-A162C、HL-A162D、HL-A163A、HL-A163B、HL-A163CRef ECA24Model HL-A240A、HL-A240B、HL-A240C
Identity
- Trade Name
- Examination Couch EUDAMED
- Device Name
- Examination Couch EUDAMED
- Model / Reference
- HL-A161A、HL-A161B、HL-A161C、HL-A162A、HL-A162B、HL-A162C、HL-A162D、HL-A163A、HL-A163B、HL-A163C EUDAMEDECA16 EUDAMEDHL-A240A、HL-A240B、HL-A240C EUDAMEDECA24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975461361622 EUDAMED06975461362407 EUDAMED
- Basic UDI-DI
- 697546136ECA16FJ EUDAMED697546136ECA24FH EUDAMED
- EMDN Code
- V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDBelgium 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
Examination Couch by Hi-Life Technology (hebei) Co., Ltd — 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 | 697546136ECA16FJ | Class I | Active |
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Manufacturer
- Manufacturer
- Hi-Life Technology (hebei) Co., Ltd
- EUDAMED SRN
- CN-MF-000023965
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED e6048d18-6009-431f-9da3-73be377221cc 61 fields · synced Sep 18, 2026
- EUDAMED b7b14874-1081-4b45-b3f1-7ef4fd0a16d4 61 fields · synced May 18, 2026