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Adhesive Strip
EUDAMEDFDA UDIClass I (EU MDR)
Ref MA2RW06Model A-2Ref MA2RW10Ref MA2RW14Ref MA2RW08
Identity
- Trade Name
- geko FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Adhesive Strip EUDAMEDAdhesive accessory A-2 FDA UDI
- Model / Reference
- A-2 EUDAMEDFDA UDIMA2RW06 EUDAMEDMA2RW10 EUDAMEDMA2RW14 EUDAMEDMA2RW08 EUDAMED
- Description
- Adhesive accessory A-2 FDA UDI
Identifiers
- Catalog Number
- MA2RW10 FDA UDI
- Primary DI / UDI-DI
- 05060294770909 EUDAMED05060294770688 EUDAMEDFDA UDI05060294771685 EUDAMED05060294771890 EUDAMED
- Basic UDI-DI
- 506029477A2NQ EUDAMED
- 510(k) Number
- K193045 FDA UDI
- FDA Product Code
- IPF FDA UDI
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Adhesive Strip by Firstkind Limited — 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 | 506029477A2NQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Firstkind Limited
- EUDAMED SRN
- GB-MF-000010541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 0256dd68-d3c6-4a92-835f-e040dfc00cf7 61 fields · synced Sep 18, 2026
- EUDAMED 8bc5e80d-5299-470b-a9b9-da92163d97c6 61 fields · synced May 17, 2026
- EUDAMED fa18250e-97b9-48dd-90c0-47af9428fab7 61 fields · synced May 17, 2026
- FDA UDI df9871f7-209c-4e64-8a7c-209fa25de8c8 35 fields · synced May 30, 2026
- EUDAMED 0235002d-9241-49fc-859f-7a41d47dca9c 61 fields · synced Jul 18, 2026