ZiboCare A/S
DK-MF-000045317 · Denmark · Horsens
ZiboCare A/S is registered in the European database on medical devices as a manufacturer, with 271 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 271 |
|---|
Most frequent device types declared: Foam Mattress, Foam Mattress accessory, Safety Mattress accessory, Sens-Aid, Sikkerhedsmadras.
Devices declared under this manufacturer
- Care 90x220x14
- Care Semi Dry 88x200x14
- Chain duvet Balanze by ZC Sensitive 12 kg 140x200
- Hypnos 1 TDI 85x180x14
- Hypnos 2 PU cover TDI 90x200x14 cm
- Hypnos 2 Soft Cover 120x220x14
- Mattress Extension 80x20x18
- Mattress Extension 86x15x14
- Mono 88x200x14
- Mono Plus 88x200x14
- Nyx Dry 80x200x14
- O-Zone duvet 14 kg 140x200 Sensitive
Showing 12 of 271 declared devices.
Catalogue references include 7000241006, 7000248002, 7010136, 8082529, 8142683, 8152090.
European nomenclature codes declared: Y99.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 271 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 271 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. ZiboCare A/S was not found in either the U.S. or the Canadian register.