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ReActiv8

EUDAMEDFDA UDI

Class AIMDD (EU MDD (legacy))

Ref 5100

by Mainstay Medical Limited

Identity

Trade Name
ReActiv8 EUDAMED
ReActiv8 IPG FDA UDI
Generic Name
PERIPHERAL NERVE IMPLANTABLE NEUROSTIMULATORS AND PAIN THERAPY LEADS EUDAMED
Implantable lumbar neuromuscular electrical stimulation system pulse generator FDA UDI
Device Name
ReActiv8 IPG EUDAMED
ReActiv8 Implantable Pulse Generator FDA UDI
Model / Reference
5100 EUDAMED
7M5100-002 FDA UDI
Description
ReActiv8 Implantable Pulse Generator FDA UDI

Identifiers

Catalog Number
5100 FDA UDI
Primary DI / UDI-DI
05391527770015 EUDAMEDFDA UDI
Basic UDI-DI
B-05391527770015 EUDAMED
PMA Number
P190021 FDA UDI
FDA Product Code
QLK FDA UDI
EMDN Code
J0210 PERIPHERAL NERVE IMPLANTABLE NEUROSTIMULATORS AND PAIN THERAPY LEADS EUDAMED
GMDN Term
Implantable lumbar neuromuscular electrical stimulation system pulse generator FDA UDI

Classification

Device Class
Class III FDA UDI
Legislation / Framework
AIMDD (Directive 90/385/EEC - Active Implantable Medical Devices) EUDAMED
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

ReActiv8 by Mainstay Medical Limited (peripheral nerve implantable neurostimulators and pain therapy leads) — Class AIMDD — AIMDD, FDA UDI — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/AIMDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mainstay Medical Limited
EUDAMED SRN
IE-MF-000017550

Sources (2)

  • EUDAMED 68 fields · synced Jun 8, 2026
  • FDA UDI e318cb7d-6145-4530-a634-987d8381d0ef 36 fields · synced May 30, 2026