Identity
- Trade Name
- HiTop 2touch EUDAMEDFDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- HiToP 2touch EUDAMEDTwo-channel physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Model / Reference
- 027-0-0010 EUDAMED027-0-0010-US FDA UDI
- Description
- Two-channel physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260364810028 EUDAMED04260364812060 FDA UDI
- Basic UDI-DI
- B-04260364810028 EUDAMED
- FDA Product Code
- GZJ FDA UDILIH FDA UDIIPF FDA UDI
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
HiTop 2touch by gbo Medizintechnik AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- gbo Medizintechnik AG
Sources (2)
- FDA UDI 87251f1f-b87b-432f-86e2-02e7e7b55389 33 fields · synced Oct 6, 2026
- EUDAMED dcf4ad34-0835-477b-b78b-8f4194c5b729 61 fields · synced Jul 21, 2026