Basic UDI-DIs
0
Scopes
4
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
Issue 2
81
Expired 81 days ago
Expiry: March 20, 2026
Basic Information
- Number
- FI23/0000008
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- May 17, 2023
- Expiry Date
- March 20, 2026 Expired
- Revision
- Issue 2
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Certificate Lifecycle
May 17, 2023
March 20, 2026
Conditions
English
PMCF investigation is to be planned and conducted for Bite Gone Model CH3000 device.
Scopes
4 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class IIa
Heat treatment device for insect stings and bites
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device Group
Class IIa
Shockwave Therapy Device
Preceding Certificates
FI23/0000008
Issued
Issued: March 21, 2023
Expires: March 20, 2026
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.