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Disposable Surgical Blades

EUDAMED

Class IIa (EU MDR)

Ref 11-0111 Sterile Disposable Surgical Blades NO. 11

by Sterilance Medical (Suzhou) Inc.

Identity

Device Name
Disposable Surgical Blades EUDAMED
Model / Reference
11-0111 Sterile Disposable Surgical Blades NO. 11 EUDAMED

Identifiers

Primary DI / UDI-DI
16945630116336 EUDAMED
Basic UDI-DI
6945630111BC EUDAMED
Unit of Use DI
06945630116339 EUDAMED
EMDN Code
V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

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

Disposable Surgical Blades by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000002860
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 4ea47fd8-3cf2-4363-a527-d63bd89be91b 61 fields · synced Jun 19, 2026