Identity
- Trade Name
- HELMED® Automated IFA Processor FDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Model / Reference
- REF.HEL-1000.US FDA UDI
Identifiers
- Catalog Number
- REF.HEL-1000.US FDA UDI
- Primary DI / UDI-DI
- 04250289513531 FDA UDI
- FDA Product Code
- JQW FDA UDI
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Specimen processing instrument IVD
HELMED® Automated IFA Processor by Aesku.Diagnostics GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI 09a263f9-f7a4-4791-ab43-524cafd071b6 33 fields · synced May 31, 2026