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High-low:xo
EUDAMEDClass I (EU MDR)
Ref 8903xx3xModel SeatingRef 8901xx2xRef 8902xx2xRef 8902xx5xRef 8903xx4xRef 8902xx4xRef 8901xx3xRef 8912xx3xRef 8902xx1xRef 8900xxxxRef 8911xx3xRef 8911xx5x
by R82 A/S
Identity
- Trade Name
- High-low:xo EUDAMED
- Model / Reference
- Seating EUDAMED8903xx3x EUDAMED8901xx2x EUDAMED8902xx2x EUDAMED8902xx5x EUDAMED8903xx4x EUDAMED8902xx4x EUDAMED8901xx3x EUDAMED8912xx3x EUDAMED8902xx1x EUDAMED8900xxxx EUDAMED8911xx3x EUDAMED8911xx5x EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05707292916181 EUDAMED05707292912381 EUDAMED05707292961952 EUDAMED05707292973108 EUDAMED05707292918390 EUDAMED05707292914545 EUDAMED05707292912343 EUDAMED05707292913296 EUDAMED05707292928467 EUDAMED05707292912077 EUDAMED05707292922267 EUDAMED05707292949349 EUDAMED
- Basic UDI-DI
- 570729212221828 EUDAMED
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
High-low:xo by R82 A/S — 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 | 570729212221828 | Class I | Active |
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Manufacturer
- Manufacturer
- R82 A/S
- EUDAMED SRN
- DK-MF-000000772
Sources (12)
- EUDAMED 0506f55d-8b08-4c36-8f25-6e0c2934d536 61 fields · synced Sep 17, 2026
- EUDAMED dab9f514-11c3-42b9-bf24-bbb334dfd17d 61 fields · synced May 16, 2026
- EUDAMED 8d667ac2-fbf5-4119-8eef-5799c41aad4e 61 fields · synced May 16, 2026
- EUDAMED 84663024-38e6-4ecc-91a5-0e4c177b2be0 61 fields · synced May 17, 2026
- EUDAMED 18d22fbb-7644-41a1-ab1d-d22f124085ed 61 fields · synced May 17, 2026
- EUDAMED 7b59c99a-2363-4a45-b472-0f5c9283d43b 61 fields · synced May 17, 2026
- EUDAMED 5374f98d-1777-46ad-acec-a573686354d0 61 fields · synced May 17, 2026
- EUDAMED b3ce83d7-fc89-4bb7-b861-a39272aa579b 61 fields · synced May 18, 2026
- EUDAMED 2b312b49-d782-4445-a47a-25ec6730896a 61 fields · synced May 18, 2026
- EUDAMED d0410e51-19a2-499e-9e16-c21d64253677 61 fields · synced May 18, 2026
- EUDAMED cf80fcc4-8175-4e1c-bd6e-7336d405d3e2 61 fields · synced May 19, 2026
- EUDAMED edbb4821-7973-48a9-983c-c9c7b6da5ea1 61 fields · synced May 19, 2026