Basic Information
- Number
- DZ 2512196-1
- Type
- MDR QA
- Legislation
- MDR
- Issue Date
- May 21, 2024
- Expiry Date
- May 20, 2029
- Revision
- Rev.0
- Manufacturer
- DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)
Certificate Lifecycle
Device Characteristics
Conditions
English
For the following product(s) the conformity assessment is limited to the aspects relating to establishing, securing and maintaining sterile conditions for systems or procedure packs pursuant to Article 22(3), REGULATION (EU) 2017/745: Sterile Surgical Packs
Scopes
Quality Procedure Scope
T020401 - STANDARD SURGICAL GOWNS T020199 - SURGICAL DRAPES - OTHER The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions. For the following product(s) the conformity assessment is limited to the aspects relating to establishing, securing and maintaining sterile conditions for systems or procedure packs pursuant to Article 22(3), REGULATION (EU) 2017/745: Sterile Surgical Packs
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.