Identity
- Trade Name
- Equate FDA UDI
- Generic Name
- Vaginal pH screening IVD, kit, rapid colorimetric, clinical FDA UDI
- Model / Reference
- F-1-VO-WAL02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290006558142 FDA UDI
- FDA Product Code
- CEN FDA UDI
- GMDN Term
- Vaginal pH screening IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Vaginal pH screening IVD, kit, rapid colorimetric, clinical
Equate by Peptonic Medical Israel Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Safecare Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- GoldN Easy to Use Vaginal pH Test — NOVODX Corporation · Class I
- Gynex — GYNEX CORPORATION · Class I
- Welcheck Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Peptonic Medical Israel Ltd
Sources (1)
- FDA UDI 581c5374-2c37-414c-9134-bd5a24a19c33 32 fields · synced Jun 8, 2026