Identity
- Trade Name
- OPTIMAX EUDAMEDFDA UDI
- Generic Name
- Darkroom automated x-ray film processor FDA UDI
- Device Name
- OPTIMAX EUDAMEDDarkroom automated x-ray film processor FDA UDI
- Model / Reference
- 1170-9-8000 EUDAMED1170 FDA UDI
- Description
- Darkroom automated x-ray film processor FDA UDI
Identifiers
- Catalog Number
- 1170-9-8000 FDA UDI
- Primary DI / UDI-DI
- 04260502640029 EUDAMEDFDA UDI
- Basic UDI-DI
- 426050264A001UA EUDAMED
- FDA Product Code
- IXW FDA UDI
- EMDN Code
- Z11070701 TRADITIONAL PROCESSORS EUDAMED
- GMDN Term
- Darkroom automated x-ray film processor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Darkroom automated x-ray film processor
Optimax by PROTEC GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Darkroom automated x-ray film processor.
- Automatic Radiographic Film Processor — Jpi Healthcare, Inc. · Class II
- OPTIMAX 2010 — PROTEC GmbH & Co. KG · Class II
- COMPACT 2 — PROTEC GmbH & Co. KG · Class II
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 II | Unknown |
| 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
- PROTEC GmbH & Co. KG
Sources (2)
- FDA UDI 1d7c9f70-f2ff-4ab4-939a-01ebfdc01a21 35 fields · synced Jul 13, 2026
- EUDAMED b2d94974-1c83-46d8-964a-0f632e833ddc 61 fields · synced Jul 13, 2026