Identity
- Trade Name
- Ramię mocowania foroptera EUDAMEDPhoropter Arm FDA UDI
- Generic Name
- Portable active medical device mount FDA UDI
- Device Name
- Phoropter Arm / Ramię mocowania foroptera EUDAMED
- Model / Reference
- PA-1000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05907642694794 EUDAMEDFDA UDI
- Basic UDI-DI
- 5907642694ARMFR EUDAMED
- Direct Marketing DI
- 05907642694794 EUDAMED
- FDA Product Code
- HMG FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Portable active medical device mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1860 FDA UDI
- Market of Registration
- Poland 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ramię mocowania foroptera by MDT sp. z o.o. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5907642694ARMFR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MDT sp. z o.o.
- EUDAMED SRN
- PL-MF-000009248
Sources (2)
- EUDAMED 61ae3d45-e16c-4f51-a05e-bb18656b3e15 61 fields · synced Jun 17, 2026
- FDA UDI badf0df5-2c8b-4c14-b336-8abe31679971 32 fields · synced May 24, 2026