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Sign in to claim this brandL I N E T spol. s r.o.
US
Last updated May 27, 2026
What L I N E T spol. s r.o. makes
The company manufactures a range of hospital and home beds, including basic electric hospital beds, kinetic beds, and powered birthing tables. Their portfolio also includes alternating-pressure mattress overlays, manual patient transfer systems, and paediatric-specific beds, as well as manual hospital stretchers for patient movement.
These devices are classified under FDA regulations as Class I or Class II and are listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to applicable U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does L I N E T spol. s r.o. manufacture?
L I N E T spol. s r.o. specializes in a variety of hospital and home-use beds and related patient support systems. Their product range includes basic electric hospital beds, kinetic beds designed for repositioning patients, and powered birthing tables for obstetric use. They also produce alternating-pressure mattress overlays to prevent pressure ulcers, manual patient transfer systems for safe movement, paediatric beds tailored for children, and manual hospital stretchers for transporting patients. These devices are engineered to support clinical care in both acute and home care settings.
Where is L I N E T spol. s r.o. based, and does this affect their device compliance?
L I N E T spol. s r.o. is based in the United States, which means their devices must comply with U.S. medical device regulations, including those set by the FDA. The company’s products are designed and manufactured to meet applicable U.S. requirements, ensuring they align with regulatory expectations for safety, performance, and quality. Compliance is determined on a device-by-device basis, as individual products may fall under different classification rules.
Which regulatory registries or databases list L I N E T spol. s r.o.’s devices?
L I N E T spol. s r.o.’s devices are included in the FDA’s Unique Device Identification (UDI) system. The UDI system assigns a unique product identifier to each device, enabling better tracking, traceability, and transparency in the healthcare supply chain. This listing helps healthcare providers, regulators, and other stakeholders verify and manage the devices in use.
How are L I N E T spol. s r.o.’s devices classified under FDA regulations?
L I N E T spol. s r.o.’s devices are classified under the FDA’s system as either Class I or Class II. Class I devices generally pose the lowest risk and may be subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in the FDA’s regulatory framework.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- linet.cz
- —
- —
- [email protected]
- Phone
- +420312576400
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 644544504
Catalogue (253)
Page 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Eleganza 5 | 1GE512055-2350 | FDA UDI | Class II | Active |
| OptiCare X | 1VSK0B0001000 | FDA UDI | Class II | Active |
| Protevo | MCM-CC | FDA UDI | Class II | Active |
| Sprint 200 | 1ES211-10 | FDA UDI | Class II | Active |
| Ave 2 | 4BCPPB3-4GC03C1 | FDA UDI | Class II | Active |
| Sprint 100 | 1ES15308-5 | FDA UDI | Class II | Active |
| Eleganza 4 | 1GE412055-671 | FDA UDI | Class II | Active |
| Eleganza 4 | 1GE412055-1235 | FDA UDI | Class II | Active |
| Sprint 100 | 1ES15409-220 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-992 | FDA UDI | Class II | Active |
| Eleganza 4 | 1GE412055-382 | FDA UDI | Class II | Active |
| Protevo | AF8-LE-35847 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-95 | FDA UDI | Class II | Active |
| Protevo | AF10MCM-VCH-35868 | FDA UDI | Class II | Active |
| Protevo | AF10-TC-35837 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-22 | FDA UDI | Class II | Active |
| Sprint 200 | 1ES210-1 | FDA UDI | Class II | Active |
| Eleganza 4 | 1GE412055-1047 | FDA UDI | Class II | Active |
| CliniCare 10P | 4PPKP1100AS | FDA UDI | Class I | Active |
| Ergozone 5000 | EZ5-EMCX | FDA UDI | Class I | Active |
| Eleganza 5 | 1GE512055-910 | FDA UDI | Class II | Active |
| Protevo | AF10-LE-35848 | FDA UDI | Class II | Active |
| Multicare | 1MC5A650-316 | FDA UDI | Class II | Active |
| Ave 2 | 1PPBA4-36 | FDA UDI | Class II | Active |
| Multicare | 1MC17350-560 | FDA UDI | Class II | Active |
| Ave 2 | 4BCPPB-GCZ004 | FDA UDI | Class II | Active |
| Multicare | 1MC5A650-101 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-11 | FDA UDI | Class II | Active |
| Tom 2 | 1K2B554-2 | FDA UDI | Class II | Active |
| Multicare | 1MC17350-561 | FDA UDI | Class II | Active |
| Multicare | 1MC17350-646 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-847 | FDA UDI | Class II | Active |
| Ave 2 | 4BCPPB3-4GC0344 | FDA UDI | Class II | Active |
| Ave 2 | 4BCPPB-BCZ0009 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-482 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-730 | FDA UDI | Class II | Active |
| Eleganza 3 | 1GZ6A100-25 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-288 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-2349 | FDA UDI | Class II | Active |
| Eleganza 4 | 1GE412055-273 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-701 | FDA UDI | Class II | Active |
| sentida 03 | 1WIS156737231062 | FDA UDI | Class II | Active |
| Eleganza 4 | 1GE412055-1043 | FDA UDI | Class II | Active |
| Opticare | 1VSM00027A000 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE412055-25 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-345 | FDA UDI | Class II | Active |
| Sprint 100 | 1ES15302-2 | FDA UDI | Class II | Active |
| Eleganza 5 | 1GE512055-286 | FDA UDI | Class II | Active |
| Symbioso 250 | 1VSM000226000 | FDA UDI | Class II | Active |
| Multicare | 1MC5A650-457 | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- LINET spol. s r.o. Slany Stredocesky Kraj · CZ FEI 3008058231