Tech Medical Device Co., Ltd.

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Manufacturer from China
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2 Years
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Tech Medical Device Co., Ltd.
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City:shenzhen
Country/Region:china
Contact Person:MrJohnson Lu
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Quality Control

Our company are managed by GMP system (ISO 13485), the following are the main management programs in place :

Tech Medical Device Co., Ltd.
List of Management Programs
# Code Name of the Program ISO13485 Item Version
1 TP-04-01 Program for Documents System 4.2.3 A/2
2 TP-04-02 Quality Control and Record Management 4.2.4 A/2
3 TP-04-03 Program of Management Duty 4.2.5 A/2
4 TP-05-01 Program for Management Assessment 5.6 A/2
5 TP-06-01 Cability and Awareness and Training 6.2.2 A/2
6 TP-06-02 Production Enviroment Control 6.3+6.4 A/2
7 TP-07-01 Customer Demand Management 7.2 A/2
8 TP-07-02 Design and Development Management 7.3 A/2
9 TP-07-03 Purchasing Management Program 7.4 A/2
10 TP-07-04 Production management Program 7.5.1 A/2
11 TP-07-05 Label and Retracable Management 7.5.3 A/2
12 TP-07-06 Store and Shipment Protection Management 7.5.5 A/2
13 TP-07-07 Serivce and Return of Goods Program 7.5.1 A/2
14 TP-07-08 Facility and Testing Devices Management 7.6 A/2
15 TP-07-09 Product Risk Management Program 7.1 A/2
16 TP-07-10 QC and Testing Control Program 7.5.3 A/2
17 TP-07-11 Sterilization Validation Control Program 7.5.2.2 A/2
18 TP-07-12 Warehouse Management Program 7.5.5 A/2
19 TP-08-01 Customer Feedback and Satisfaction Mgmt 8.2.1 A/2
20 TP-08-02 Quality System Internal Assessment 8.2.2 A/2
21 TP-08-03 Product Monitoring and Measurement 8.2.4 A/2
22 TP-08-04 Management for Disqualified Products 8.3 A/2
23 TP-08-05 Data Analisis Management 8.4 A/2
24 TP-08-06 Improvement and Corrrection Management 8.5 A/2
25 TP-08-07 Adverse Event and Notice Control 8.5.1 A/2
26 TP-08-08 Early Fault Alarm Management 8.2.1 A/2
27 TP-08-09 Investgation of Customer Complaining 8.2.1 A/2
28 TP-08-10 Validation Management 7.5.2.2 A/2
29 TP-08-11 Contract Evaluation Process 8.2.1 A/2

Our testing instruments can be grouped into 2 kinds: Electrical Testing Instruments, Biological Testing Instruments. The following pictures are only a part of our testing instruments.

The Electrical Testing Instruments (showed) include:

1) Hi-Frequency Generator;

2) 9000V High votage Testing machine.

3) Electric Currency Testing Device

The Biological Testing Instruments (showed) include:

1) Microscope

2) Micro-dust Testing Instrument.

3) Ultraviolet Spectrophotometer

4) 10k degree testing room

5) 100 degree biological Safety Cabin

Certifications
Tech Medical Device Co., Ltd. Certifications
Standard: SFDA
Number: #20192010280
Issue Date: 2019-04-01
Expiry Date: 2024-03-31
Scope/Range: TD1/TD2 Series
Issued By: SFDA
Tech Medical Device Co., Ltd. Certifications
Standard: SFDA
Number: #20142010212
Issue Date: 2019-10-14
Expiry Date: 2024-10-13
Scope/Range: TD4 Series
Issued By: SFDA
Tech Medical Device Co., Ltd. Certifications
Standard: SFDA
Number: #20142010206
Issue Date: 2019-07-19
Expiry Date: 2024-07-18
Scope/Range: Focepts for Hi-Frequency Generator
Issued By: SFDA
Tech Medical Device Co., Ltd. Certifications
Standard: Patent
Number: 9707270
Issue Date: 2019-12-03
Expiry Date: 2029-12-02
Scope/Range: TD1 Series
Issued By: CNIPA
Tech Medical Device Co., Ltd. Certifications
Standard: SFDA
Number: #20182020903
Issue Date: 2023-06-21
Expiry Date: 2028-10-22
Scope/Range: TQ Series
Issued By: SFDA
Tech Medical Device Co., Ltd. Certifications
Standard: Patent
Number: 11660896
Issue Date: 2020-10-16
Expiry Date: 2030-10-15
Scope/Range: TD1 Series
Issued By: CNIPA
Tech Medical Device Co., Ltd. Certifications
Standard: Patent
Number: 5133314
Issue Date: 2016-04-13
Expiry Date: 2026-04-12
Scope/Range: TD1 Series
Issued By: CNIPA
Tech Medical Device Co., Ltd. Certifications
Standard:
Number:
Scope/Range:
Issued By:
Tech Medical Device Co., Ltd. Certifications
Standard: Patent
Number: 9703258
Issue Date: 2019-12-03
Expiry Date: 2029-12-02
Scope/Range: TD1 Series
Issued By: CNIPA
Company Profile
Tech Medical Device Co., Ltd.
Contact Person: MrJohnson Lu