Identity
- Trade Name
- WALL TRANSFORMER EN 200 FDA UDI
- Generic Name
- Constant-voltage transformer FDA UDI
- Model / Reference
- 000 FDA UDI
Identifiers
- Catalog Number
- X-095.12.250 FDA UDI
- Primary DI / UDI-DI
- 04053755199679 FDA UDI
- FDA Product Code
- HJM FDA UDIHMF FDA UDI
- GMDN Term
- Constant-voltage transformer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1945 FDA UDI886.1860 FDA UDI
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Constant-voltage transformer
Wall Transformer En 200 by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Constant-voltage transformer.
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz — EB NEURO SPA · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA · Class II
- WALL TRANSFORMER EN 200-1 — Heine Optotechnik GmbH & Co. KG · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heine Optotechnik GmbH & Co. KG
Sources (1)
- FDA UDI 34755a77-d7a6-4ad0-9e99-632d4e79f226 34 fields · synced May 31, 2026