Exdia Thyroid Control
Ref PR-FQ08
Exdia Thyroid Control (PR-FQ08) is a Class B device made by Precision Biosensor Inc., registered in EUDAMED on 18 Jun 2026 (Basic UDI-DI 8800026300922VT) with CE/IVDR certificate V76 099231 0005 valid until 31 May 2031, active as of 25 Oct 2026.
Active
CE IVDR
Valid until
31 May 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8800026300922VT 08800026300922 | Date18 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 8800026300922VT
Certificates
- V76 099231 0005 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 1 Jun 2026
- Expires
- 31 May 2031
Timeline
- Certificate issued EUDAMED V76 099231 0005
- Registered EUDAMED 8800026300922VT
- Certificate expires EUDAMED V76 099231 0005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Exdia Thyroid Control
- Model / reference
- PR-FQ08
- Primary DI / UDI-DI
- 08800026300922
- Basic UDI-DI
- 8800026300922VT
- EMDN code
- W0102152008 Controls for individual and specific hormones
- Device class
- Class B
- EU registration type
- Standard device
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- KR-MF-000034861
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Similar devices in this category
Other devices filed under CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES.
- LIAISON® N-TACT® PTH Gen II Control Set 317911 by Diasorin Inc.
- Monobind Qsure TBG Control Set TBG-300 by MONOBIND, INC.
- LIAISON® Control Insulin 310361 by Diasorin Inc.
- ADVIA Centaur® PTH 10699156 by Siemens Healthcare Diagnostics Inc.
- Atellica IM DHEAS2 MCM SET 11209195 by Siemens Healthcare Diagnostics Inc.
- IDS High Sensitive Estradiol Control Set IS-5230HS by Immunodiagnostic Systems Limited
- IDS-iSYS Insulin-like Growth Factor-I (IGF-I) Control Set IS-3930 by Immunodiagnostic Systems Limited
- IMMULITE® Systems IG1 CONTROL IGF-1 10385387 LGCOCM by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Growth Hormone Multi Control (L) 105-037812-00 by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Diazyme Procalcitonin Control Set DZ558A-CON by Diazyme Laboratories, Inc.