FHD Multiscope [3.1 mm WCh] with Ocular

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref MS5830125O

by Joimax GmbH

Identity

Trade Name: FHD Multiscope [3.1 mm WCh] with Ocular EUDAMED
FHD Multiscope (3.1 mm WCh) with Ocular EUDAMED
joimax® FDA UDI
Generic Name: Spinal endoscopic-access system FDA UDI
Device Name: FHD Multiscope [3.1 mm WCh] with Ocular EUDAMED
TESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo EUDAMED
HD Multiscope [3.1 mm WCh] with Ocular FDA UDI
Model / Reference: MS5830125O EUDAMEDFDA UDI
Description: HD Multiscope [3.1 mm WCh] with Ocular FDA UDI

Identifiers

Primary DI / UDI-DI: 04250337105787 EUDAMEDFDA UDI
Basic UDI-DI: B-04250337105787 EUDAMED
42503371ENSCFORG9 EUDAMED
Direct Marketing DI: 04250337105787 EUDAMED
510(k) Number: K051827 FDA UDI
FDA Product Code: HRX FDA UDI
EMDN Code: Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
GMDN Term: Spinal endoscopic-access system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscope obturator

FHD Multiscope [3.1 mm WCh] with Ocular by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-04250337105787	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-04250337105787	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Joimax GmbH
EUDAMED SRN: DE-MF-000009201

Sources (3)

EUDAMED 34481fb7-a999-4941-afa5-4c95a73cd146 61 fields · synced Jul 20, 2026
FDA UDI 29d46fac-2b89-4c88-b751-b67689a134a6 35 fields · synced May 30, 2026
EUDAMED c286fb1c-0f7a-481c-96de-cc2bcc2c7f37 61 fields · synced Jul 20, 2026