Identity
- Trade Name
- Norco Compression Gloves EUDAMEDNorco Iontophoresis Small Sample FDA UDI
- Generic Name
- Drug-delivery iontophoresis patch FDA UDI
- Device Name
- Norco Compression Gloves EUDAMEDNorco Buffered Iontophoresis Delivery Kit- Small Sample Pack (2) FDA UDI
- Model / Reference
- 2054 EUDAMEDNC53207 EUDAMEDSA89250B FDA UDI
- Description
- Norco Buffered Iontophoresis Delivery Kit- Small Sample Pack (2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768627001731 EUDAMEDFDA UDI
- Basic UDI-DI
- 07686272054S7 EUDAMED
- Direct Marketing DI
- 00768627001731 EUDAMED
- FDA Product Code
- EGJ FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Drug-delivery iontophoresis patch FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Compression/pressure sock/stocking, reusable
Norco Compression Gloves by North Coast Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 07686272054S7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED b325bb7d-ba52-4dc8-ba28-1296bcbcfa0c 61 fields · synced Jul 9, 2026
- FDA UDI 29827b8c-9106-4e9a-93e4-334156605073 33 fields · synced May 30, 2026