Identity
- Trade Name
- Envoy ISE Conditioner FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Model / Reference
- 55153 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700829317 FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Wash/cleaning solution IVD, automated/semi-automated system
Envoy ISE Conditioner by Vitalscientific — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wash/cleaning solution IVD, automated/semi-automated system.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
- DAB Away — BIOCARE MEDICAL, LLC · Class I
- ACE — Alfa Wassermann, Inc.
- ADVIA 120/212-/2120i Perox Flow Cell Wash Kit — Siemens Healthcare Diagnostics · Class I
- ADVIA® 360/560 Hypoclean 100 mL — Siemens Healthcare Diagnostics · Class II
- Capillary Adapter Cleaning Kit — Medica Corp. · Class II
- Dimension® Reagent Probe Cleaner — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® Cleaning Solution Concentrate — Siemens Healthcare Diagnostics · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitalscientific
Sources (2)
- FDA UDI f430bb5b-0466-4210-9e18-ef3e75c28dc0 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026