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ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0025513
Identity
- Trade Name
- ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, reagent FDA UDI
- Device Name
- ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION EUDAMED
- Model / Reference
- 0025513 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211414 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189211414 EUDAMED
- FDA Product Code
- CEW FDA UDI
- EMDN Code
- W0102060312 PARATHYROID HORMONE INTACT EUDAMED
- GMDN Term
- Parathyroid hormone (PTH) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1545 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION by Tosoh Corporation — 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-04560189211414 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED a9fe2632-5771-4bc8-8a2a-e46c72e30ecb 61 fields · synced Jun 18, 2026
- FDA UDI eae4a05d-8f59-47a3-a004-380a0e3b20df 34 fields · synced May 30, 2026