No Certificate Found

Snapshot 2026-10-19 · Link to EUDAMED

Comfort Cool Ulnar/Dorsal Wrist Orthotic, RM

UDI-DI 00768627795036Basic UDI-DI 0768627ORTHO-1165-N7

Class I · MDR · North Coast Medical Inc.

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Identification

Model: 1165
EMDN: Y060612
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-19 · Link to EUDAMED

Manufacturer

North Coast Medical Inc.

SRN US-MF-000009087

US · Morgan Hill, California

manufacturer

Authorised representative: ICON (LR) Limited (IE-AR-000006507)

Related UDI-DIs

Comfort Cool Ulnar/Dorsal Wrist Orthotic, LL 00768627795043
Comfort Cool Ulnar/Dorsal Wrist Orthotic, LM 00768627795029
Comfort Cool Ulnar/Dorsal Wrist Orthotic, LS 00768627795005
Comfort Cool Ulnar/Dorsal Wrist Orthotic, RL 00768627795050
Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS 00768627795012

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/comfort-cool-ulnar-dorsal-wrist-orthotic-rm-5036 · UDI page: /udi/00768627795036

All devices from North Coast Medical Inc.

Scan an inventory CSV