Identity
- Trade Name
- VCA Lite EUDAMEDFDA UDI
- Generic Name
- Vaginal applicator, single-use FDA UDI
- Device Name
- VCA Lite EUDAMED5.3 cc Vaginal Cream Applicator in a 7-pack canister FDA UDI
- Model / Reference
- Q033-G00-01 EUDAMEDFDA UDI
- Description
- 5.3 cc Vaginal Cream Applicator in a 7-pack canister FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009492905 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600094929Q033K7 EUDAMED
- Unit of Use DI
- 20860009492909 EUDAMED
- FDA Product Code
- HGD FDA UDI
- EMDN Code
- U089009 VAGINAL APPLICATORS, SINGLE-USE EUDAMED
- GMDN Term
- Vaginal applicator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal applicator, single-use
VCA Lite by Pce, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pce, Inc.
Sources (2)
- FDA UDI 45ac3033-6ebd-45cf-b5e7-2d0bd4f6f4da 33 fields · synced Jul 26, 2026
- EUDAMED 17689c6c-cc9e-4569-8176-b68f02e6fb0b 61 fields · synced Jul 26, 2026