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21.0008a

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 21.0008aModel Arthroscopes

by Schölly Fiberoptic Gmbh

Identity

Trade Name
NA FDA UDI
Generic Name
Rigid optical arthroscope, reusable FDA UDI
Device Name
Arthroscope 4 x 175 mm, 30° FDA UDI
Model / Reference
Arthroscopes EUDAMED
21.0008a EUDAMEDFDA UDI
Description
Arthroscope 4 x 175 mm, 30° FDA UDI

Identifiers

Primary DI / UDI-DI
04250480101490 EUDAMEDFDA UDI
Basic UDI-DI
42504801ARTHROSCOPESSU EUDAMED
Direct Marketing DI
04250480101490 EUDAMED
FDA Product Code
HRX FDA UDI
EMDN Code
Z12021101 ARTHROSCOPES EUDAMED
GMDN Term
Rigid optical arthroscope, reusable 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

21.0008a by SCHÖLLY FIBEROPTIC GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Schölly Fiberoptic Gmbh
EUDAMED SRN
DE-MF-000005618

Sources (3)

  • EUDAMED d25be39e-da8a-43de-a243-588b2c271045 61 fields · synced Jul 14, 2026
  • FDA UDI b7174da9-0a6a-4ff8-8d74-dacd1ad09c42 36 fields · synced May 30, 2026
  • FDA 510(k) K133682 1 fields · synced May 18, 2026