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Sample Diluent
EUDAMEDFDA UDIClass A (EU MDR)
Ref C89915Model ERef C89927Model L
Identity
- Trade Name
- Sample Diluent FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Sample Diluent EUDAMEDSample Diluent D, 45 mL×2 bottles FDA UDI
- Model / Reference
- E EUDAMEDC89915 EUDAMEDFDA UDIL EUDAMEDC89927 EUDAMED
- Description
- Sample Diluent D, 45 mL×2 bottles FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912716631 EUDAMEDFDA UDI06925912735465 EUDAMED
- Basic UDI-DI
- 692591270175HM EUDAMED692591270299J8 EUDAMED
- Unit of Use DI
- 06925912740254 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Spain EUDAMEDGermany 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
Yes
EUDAMEDEUDAMED
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sample Diluent by Shenzhen Yhlo Biotech Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 692591270175HM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED fb96aad7-01e5-4acd-83a0-ad47a5dd0add 61 fields · synced Aug 2, 2026
- FDA UDI 7e933966-944b-435b-953f-af34a84e1320 33 fields · synced May 30, 2026
- EUDAMED d45eb9e2-6876-4063-8adb-9264b2754612 61 fields · synced Aug 2, 2026