Identity
- Device Name
- Back Pad EUDAMED
- Model / Reference
- 810-11113-00 EUDAMED204-00081-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850043319030 EUDAMED00850043319153 EUDAMED
- Basic UDI-DI
- 0860000606100002R5 EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
Back Pad by Hyperfine, Inc. — 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 | 0860000606100002R5 | Class I | Active |
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Manufacturer
- Manufacturer
- Hyperfine, Inc.
- EUDAMED SRN
- US-MF-000029806
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b5d682af-3345-403b-b8fc-c007d8ecb2cb 61 fields · synced Jul 27, 2026
- EUDAMED 7a3c71f7-5bac-4e21-bd5f-75f9cf0c6bc0 61 fields · synced Jul 18, 2026