Identity
- Trade Name
- Ekran Hessa EUDAMEDHess Screen FDA UDI
- Generic Name
- Hess-screen FDA UDI
- Device Name
- Hess Screen / Ekran Hessa EUDAMED
- Model / Reference
- EH-1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05907642694886 EUDAMEDFDA UDI
- Basic UDI-DI
- 5907642694EH1DR EUDAMED
- Direct Marketing DI
- 05907642694886 EUDAMED
- FDA Product Code
- HOK FDA UDI
- EMDN Code
- Q0209 STRABISMUS DEVICES EUDAMED
- GMDN Term
- Hess-screen FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1810 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
Category: Hess-screen
Hess Screen by Mdt Sp Z O O — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hess-screen.
- Clement Clarke Ophthalmic — HAAG-STREIT UK LIMITED · Class I
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
- Mdt Sp Z O O
Sources (2)
- FDA UDI d49247c3-7ced-44c8-bf19-9d315ea128f9 32 fields · synced Jun 19, 2026
- EUDAMED 2b4bce41-b690-4f38-bb94-1b9d3fa4c572 61 fields · synced Jun 19, 2026