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Bio30+ Physio W/O A/S HP
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 80-6000-55Model Bio30+
Identity
- Trade Name
- Bio 30+ Physio W/O A/S HP EUDAMEDBio30+ Physio W/O A/S HP FDA UDI
- Generic Name
- Amino acid analyser IVD FDA UDI
- Device Name
- Bio30+ Amino Acid Analyzer EUDAMEDIon exchange chromatography analyzer sold with lithium high performance column. FDA UDI
- Model / Reference
- 80-6000-55 EUDAMEDFDA UDIBio30+ EUDAMED
- Description
- Ion exchange chromatography analyzer sold with lithium high performance column. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056336800253 EUDAMEDFDA UDI
- Basic UDI-DI
- 50563368AAAIVDSC0013Q EUDAMED
- Direct Marketing DI
- 05056336800253 EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Amino acid analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Market of Registration
- Germany 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
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Amino acid analyser IVD
Bio30+ Physio W/O A/S HP by Biochrom Limited — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Amino acid analyser IVD.
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- Bio30+ System Physio HP — BIOCHROM LIMITED · Class I
- Bio30+ Physio W/O A/S HR — BIOCHROM LIMITED · Class I
- Bio30+ Physio High Performance — BIOCHROM LIMITED · Class I
- Bio30+ System Physio HR — BIOCHROM LIMITED · Class I
- Bio30+ Physiological HR — BIOCHROM LIMITED · Class I
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
- Biochrom Limited
Sources (2)
- FDA UDI ae75d7d4-286d-47d9-90d2-72aac2589e31 33 fields · synced Oct 6, 2026
- EUDAMED 36a56948-d86d-4b1f-b4b9-348c1988884d 61 fields · synced Jul 13, 2026