Documentation

氧帆文档与核验中心

本资料库用于买方和项目审核。每份文件均标明法律实体、型号范围、出具机构、签发日期和限制。这些文件不能替代当地法规、安装或专业审核。

DocumentLegal entityModel scopeIssuerNumberIssue dateExpiry dateStatusFile
CE Verification of Conformity Osail(Jinan) Intelligent Technology Co., Ltd. Hyperbaric Chamber, YCDY-W100 Series ICR Co., Ltd. ICR/VC/HS2508147 (S/N 016797) 2025-08-22 2030-08-21 Current 查看文件
SGS Inspection Report - SHINIPC2600653S01 Jinan Oxysail Health Technology Co., Ltd. Hard Hyperbaric Chamber: YF-1002, YF-1004, YF-2003, YF-1005 and YF-4002 SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. SHINIPC2600653S01 2026-09-02 Not stated in report Current 查看文件
Third-Party Supplier Assessment Jinan Yangfan Intelligent Equipment Co., Ltd. / 济南氧帆智能设备有限公司 Company-level only SGS / Alibaba.com verification programme 483535014_T 2026-01-04 2027-01-04 Current 查看文件

产品符合性文件

CE Verification of Conformity

CE Verification of Conformity

Current

文件类型
Voluntary verification of conformity
法律实体
Osail(Jinan) Intelligent Technology Co., Ltd.
型号范围
Hyperbaric Chamber, YCDY-W100 Series
出具机构
ICR Co., Ltd.
证书或报告编号
ICR/VC/HS2508147 (S/N 016797)
适用标准
MD 2006/42/EC; EMC 2014/30/EU; standards listed in the document
签发日期
2025-08-22
有效期
2030-08-21
当前状态
Current

核验网址: https://www.icrqa.com/

文件证明什么: The document records a conformity verification for the product, legal entity and YCDY-W100 Series scope stated in it.

文件不证明什么: This is not FDA clearance or U.S. market authorization. The document states that the voluntary verification does not itself demonstrate every essential requirement or replace any required notified-body assessment.

压力与安全检测文件

SGS Inspection Report - SHINIPC2600653S01

SGS Inspection Report - SHINIPC2600653S01

Current

文件类型
Non-negotiable inspection report
法律实体
Jinan Oxysail Health Technology Co., Ltd.
型号范围
Hard Hyperbaric Chamber: YF-1002, YF-1004, YF-2003, YF-1005 and YF-4002
出具机构
SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd.
证书或报告编号
SHINIPC2600653S01
适用标准
ASME PVHO-1 2023; ASME Section VIII Division 1, 2023
签发日期
2026-09-02
有效期
Not stated in report
当前状态
Current

核验网址: https://www.sgs.com/en-cn/consumer-products-retail

文件证明什么: The report records SGS witnessing of hydrostatic pressure testing for the listed chamber models. The required test pressure was 0.2 MPa(g), actual test pressure was 0.2-0.26 MPa(g), and the reported result was satisfactory with no leakage observed during the required inspection.

文件不证明什么: This is an inspection report for the stated intervention and scope. It is not a medical-device authorization, FDA clearance, or a blanket approval for models not listed in the report.

第三方供应商评估

Third-Party Supplier Assessment

Third-Party Supplier Assessment

Current

文件类型
Company-level trade assessment
法律实体
Jinan Yangfan Intelligent Equipment Co., Ltd. / 济南氧帆智能设备有限公司
型号范围
Company-level only
出具机构
SGS / Alibaba.com verification programme
证书或报告编号
483535014_T
适用标准
Trade Assessment
签发日期
2026-01-04
有效期
2027-01-04
当前状态
Current

核验网址: http://auditedsupplier.sgsgroup.com.cn

文件证明什么: This is a company-level supplier assessment for the named company and assessment period.

文件不证明什么: This is not a product safety certificate, pressure-vessel approval or FDA authorization.

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