← Back to catalogue
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-A163C
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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975461361639 EUDAMED
- Basic UDI-DI
- 697546136ECA16FJ EUDAMED
- EMDN Code
- V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hi-Life Technology (hebei) Co., Ltd
- EUDAMED SRN
- CN-MF-000023965
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9cea4715-82d5-4cb3-bbce-e4efefdc3bb8 61 fields · synced Jun 19, 2026