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VH2O2 Indicator Strip
EUDAMEDFDA UDIClass I (EU MDR)
Ref GPS-250RModel Chemical Indicators
Identity
- Trade Name
- VH2O2 Indicator Strip EUDAMEDVH202 INDICATOR STRIP RED FDA UDI
- Generic Name
- Chemical/physical sterilization process indicator FDA UDI
- Device Name
- ISO 11140-1 Type 1, 4 in (10 cm) FDA UDI
- Model / Reference
- Chemical Indicators EUDAMEDGPS-250R EUDAMEDFDA UDI
- Description
- ISO 11140-1 Type 1, 4 in (10 cm) FDA UDI
Identifiers
- Catalog Number
- GPS-250R FDA UDI
- Primary DI / UDI-DI
- 10732224710621 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224ChemIndicator6N EUDAMED
- Unit of Use DI
- 00732224710624 EUDAMED
- FDA Product Code
- JOJ FDA UDI
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Chemical/physical sterilization process indicator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
VH2O2 Indicator Strip by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224ChemIndicator6N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Sources (2)
- EUDAMED 7a557bd2-0b8e-4cb7-a82e-f9416f878b3c 61 fields · synced Oct 6, 2026
- FDA UDI a3b08de1-f80b-422a-a095-61b3f5679ac1 36 fields · synced May 30, 2026