Company
Czech RepublicDeymed Diagnostic SRO, Hronov, Czech Republic – FDA Inspections
Inspection records and compliance data for Deymed Diagnostic SRO in Hronov. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 27, 2025.
Company Profile
This profile covers Deymed Diagnostic SRO based in Hronov, Czech Republic.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 27, 2023. Last inspected March 27, 2025.
Most cited issue areas
- Design control - no procedures1 inspection
- Label to bear a unique device identifier1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 27, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1268057 |
| July 27, 2023 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1214862 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Deymed Diagnostic SRO
FEI Number
3012168464
Address
Kudrnacova 533, Hronov, Czech Republic
Country
Czech Republic
ID: 227737ad-7694-4077-a922-90210bb3ddec