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extendSURETM Haemoglobin F and A2 Calibrators
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref HB110SCALAr Model HB110SCALAr
Identity
- Trade Name
- extendSURETM Haemoglobin F and A2 Calibrators EUDAMEDExtendSURE FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, calibrator FDA UDI
- Device Name
- extendSURETM Haemoglobin F and A2 Calibrators EUDAMEDThe lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator which are prepared as a stabilized hemolysate from human blood. The calibrators are designed to establish known points of reference in laboratory testing procedures. FDA UDI
- Model / Reference
- HB110SCALAr EUDAMEDFDA UDI
- Description
- The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator which are prepared as a stabilized hemolysate from human blood. The calibrators are designed to establish known points of reference in laboratory testing procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421902348044 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09421902348044 EUDAMED
- FDA Product Code
- JCM FDA UDI
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
- GMDN Term
- Multiple haemoglobin subtype IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7415 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
extendSURETM Haemoglobin F and A2 Calibrators by Canterbury Scientific Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-09421902348044 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Canterbury Scientific Limited
- EUDAMED SRN
- NZ-MF-000001778
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8c53831c-e7e8-41fa-b659-f7d9c594a9f4 61 fields · synced Jun 18, 2026
- FDA UDI 5dad4b95-d487-45f1-a084-39b4443a3535 34 fields · synced May 30, 2026