Identity
- Trade Name
- Pre-Trigger Solution (1×) FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Pre-Trigger Solution (1x) EUDAMED220 mL×4 bottles FDA UDI
- Model / Reference
- C89949 EUDAMEDFDA UDI
- Description
- 220 mL×4 bottles FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912716129 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270170HB EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- France 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
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
Pre-Trigger Solution (1x) 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 | 692591270170HB | 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 (2)
- EUDAMED 514b7e41-43be-41c5-b074-f50e0aba63fa 61 fields · synced Jun 18, 2026
- FDA UDI c421f1ae-e326-4c87-b438-ffb6e506c5b3 33 fields · synced May 29, 2026