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Tatras Gerlach E-S2.f4
EUDAMEDFDA UDIClass I (EU MDR)
Ref -Model TERAPEUTA, MONTANE, PRESTIGE, Z-ULTIMATE, ELEMENTAL
Identity
- Trade Name
- TATRAS GERLACH E-S2.F4 EUDAMEDMONTANE TATRAS GERLACH E-S2.F4 [SZER. 69 CM] FDA UDI
- Generic Name
- Examination/treatment table, line-powered FDA UDI
- Device Name
- Stół do masażu EUDAMEDThe MONTANE treatment table is a treatment table that facilitates manual therapies and massage treatment by enabling the patient to assume the proper position for treatment and to adjust the height and/or position each table section. FDA UDI
- Model / Reference
- TERAPEUTA, MONTANE, PRESTIGE, Z-ULTIMATE, ELEMENTAL EUDAMED- EUDAMED01-STO-3031-001 FDA UDI
- Description
- The MONTANE treatment table is a treatment table that facilitates manual therapies and massage treatment by enabling the patient to assume the proper position for treatment and to adjust the height and/or position each table section. FDA UDI
Identifiers
- Catalog Number
- 3525 FDA UDI
- Primary DI / UDI-DI
- 05903684800315 EUDAMEDFDA UDI
- Basic UDI-DI
- 590368480M035BS EUDAMED
- FDA Product Code
- INQ FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Examination/treatment table, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3760 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
Tatras Gerlach E-S2.f4 by Meden Inmed 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 | 590368480M035BS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meden-Inmed Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000001670
Sources (2)
- EUDAMED b4902b6b-1156-4b92-a2b3-2eb7884a7f94 61 fields · synced Oct 6, 2026
- FDA UDI dab8c504-a055-4000-b698-9533e5783623 34 fields · synced May 30, 2026