Regulatory
Regulatory status and certifications
Market registrations, quality certifications and manufacturer details for procurement review.
01 / Market access
Regulatory status by market
CarbonCool® Full Body Suit™ regulatory status across international markets.
European conformity
MDR CE marked. See the market register below for registration and clearance details.
| Regulator / pathway | Market | Registration / clearance number |
|---|---|---|
| FDA 510(k) | United States | K240933 |
| MDR CE Mark | European Union | - |
| HSA | Singapore | - |
| PMDA | Japan | - |
| TGA | Australia | - |
| MDA | Malaysia | - |
| Thai FDA | Thailand | - |
| MOH | Vietnam | - |
| FDA | Philippines | - |
| KEMENKES RI | Indonesia | AKL 11403026727 |
Not all products are available in all markets. Regulatory status varies by country. Contact our team or see Regulatory status.
FDA 510(k) K240933
FDA 510(k) database, K240933
02 / Full Body Suit
Full Body Suit regulatory profile
CarbonCool® devices are for use by trained medical personnel only.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
- Device class
- United States: Class II, 21 CFR 870.5900 (Thermal regulating system), product code NZE
- FDA 510(k)
- K240933
- EU authorised representative
- MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany
- Intended user
- Trained medical personnel
Indications for use
Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
Contraindications
- Skin diseases
- Bedsore
- Inflammation
- Burns or other skin injuries
Precautions
- Use is at the sole discretion of the treating physician.
- Check skin condition before and during application. Do not apply on harmed skin such as skin disease, burns, irritation or open wounds.
- Patients with cryoglobulinemia, sickle cell anaemia, cold agglutinins, poor tissue perfusion or poor skin integrity are at higher risk of cold or pressure injury. Do not use if any of these conditions is present.
- Do not apply to the genital region, female breast tissue, toes, fingers or face.
- Do not use on pregnant women.
- For patients under 35 kg body weight the system may only be used for normothermia treatment.
- Use with an appropriate core temperature monitoring device.
Full instructions for use, warnings and precautions are supplied with the product and available on request.
03 / Quality
Quality management system
- ISO 13485:2016 certified
- Medical device quality management systems.
- SS 620:2016
- Singapore medical device distribution standards.
04 / Legal entities
Legal manufacturer
- Legal manufacturer
- Global Healthcare SG Sdn. Bhd.Lot 43824, Jln Tech Valley 2/1Bandar Sri Sendayan71950 Seremban, Negeri SembilanMalaysia
- EU authorised representative
- MDSS GmbHSchiffgraben 4130175 HannoverGermany
- Headquarters
- Global Healthcare SG Pte Ltd203 Henderson Road #12-07Henderson Industrial ParkSingapore 159546
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