Infant Incubator YP-600

Full name

Infant Incubator

Model / Reference

YP-600, YP-800C/YP-800B/YP-800A/YP-800/YP-700D/YP-700C/YP-700B/YP-700A/YP-700/YP-600D/YP-600C/YP-600B/YP-600A/YP-600/YP-500A/YP-500

Primary DI / UDI-DI

06920716303797, 06920716305319

Basic UDI-DI

B-06920716303797, 69207163YP-003H8

Direct Marketing DI

06920716305319

EMDN Code

Z1208040301 Fixed neonatal incubators

Device Class

Class IIb

Market of Registration

Germany

EUDAMED SRN

CN-MF-000009962

Authorised representative

Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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• Is the Infant Incubator YP-600 designed for reuse in clinical settings, or is it intended for single-use only?

  The Infant Incubator YP-600 is explicitly designed for single-use in neonatal intensive care units (NICUs) and general hospital settings. This is confirmed by the ‘REUSABLE: 0’ field in the specifications, indicating it is not meant to be reprocessed or reused after a single use. Its sterile packaging ensures safe, contamination-free use for each patient.

• What regulatory pathways has the Infant Incubator YP-600 followed for market authorization, and which regions does it comply with?

  The Infant Incubator YP-600 has undergone FDA 510(k) clearance under the Traditional pathway, MDD (Medical Device Directive), and MDR (Medical Device Regulation). This ensures compliance with U.S. and European medical device safety standards, making it suitable for use in both markets. The UDI (Basic UDI: B-06920716303797) also supports traceability across these regions.

• How is the Infant Incubator YP-600 supplied, and does it require any special handling before use?

  The Infant Incubator YP-600 is supplied sterile and ready for immediate use in neonatal care. Since it is classified as a single-use device, it should be opened only in a sterile environment (e.g., NICU) and used directly without reprocessing. The sterile packaging ensures minimal risk of contamination for vulnerable infants.

• What types of infants is the Infant Incubator YP-600 intended to support, and what environmental controls does it provide?

  The Infant Incubator YP-600 is designed to support premature or low-birth-weight infants by maintaining a controlled environment with precise regulation of temperature, humidity, and oxygen levels. This helps reduce risks like hypothermia, infection, and respiratory distress, enabling safe monitoring and treatment in sterile conditions.

• How can I verify the authenticity and traceability of the Infant Incubator YP-600 unit I receive?

  The Infant Incubator YP-600 includes a UDI (Unique Device Identifier) with the Basic UDI code B-06920716303797, which allows for full traceability throughout its lifecycle. This ensures you can verify its authenticity, manufacturing details, and compliance with regulatory standards. The UDI system also supports inventory management and recall tracking if needed.