Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
01
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446
Valid for 446 days
Expiry: October 16, 2027
Basic Information
- Number
- 006-00-01-MDR
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- November 11, 2022
- Expiry Date
- October 16, 2027
- Revision
- 01
- Manufacturer
- Mt Ortho
Certificate Lifecycle
Today
November 11, 2022
October 16, 2027
Device Characteristics
Sterile
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Custom Made Device
Class III custom-made orthopaedic implantable devices as devices for vertebral surgery, devices for maxillofacial surgery and orthopedic devices in contact with central nervous system
Quality Procedure Scope
Device Group
Class III
Class III custom-made non-active orthopaedic implantable devices
Preceding Certificates
006-00-00-MDR
Issued
Issued: October 17, 2022
Expires: October 16, 2027
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.