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Helmed® Automated Ifa Processor
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref REF.HEL-1000Model 20110009
Identity
- Trade Name
- HELMED® AUTOMATED IFA PROCESSOR EUDAMEDFDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- HELMED® Automated IFA Processor EUDAMED
- Model / Reference
- REF.HEL-1000 EUDAMEDFDA UDI20110009 EUDAMED
Identifiers
- Catalog Number
- REF.HEL-1000 FDA UDI
- Primary DI / UDI-DI
- 04250289512565 EUDAMEDFDA UDI
- Basic UDI-DI
- 42502895HELMEDFH EUDAMED
- Direct Marketing DI
- 04250289512565 EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Helmed® Automated Ifa Processor by Aesku.Diagnostics GmbH & Co. KG — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| 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 (2)
- FDA UDI bd06d19b-d516-4986-bffe-d74031a1f4ab 34 fields · synced Oct 6, 2026
- EUDAMED 05f2e7eb-b7ab-4422-9727-29d21a4d099a 61 fields · synced Oct 6, 2026