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mediware

EUDAMED

Class IIa (EU MDR)

Ref I1 0824 CARBON STEEL 24#Ref I1 0822 CARBON STEEL 22#Ref SS #15Ref I1 0819 CARBON STEEL 19#Ref I1 0812 CARBON STEEL 12#Ref SS #22Ref I1 0820 CARBON STEEL 20#Ref I1 0811 CARBON STEEL 11PY#Ref SS #11Ref I1 0821 CARBON STEEL 21#Ref SS #18Ref SS #23Ref SS #19Ref SS #24Ref I1 0818 CARBON STEEL 18#Ref SS #21Ref SS #12Ref "Asurity SS 10# I19910"

by Sterilance Medical (Suzhou) Inc.

Identity

Trade Name
mediware EUDAMED
Device Name
Disposable Surgical Blades EUDAMED
Disposable Scalpels EUDAMED
Model / Reference
I1 0824 CARBON STEEL 24# EUDAMED
I1 0822 CARBON STEEL 22# EUDAMED
SS #15 EUDAMED
I1 0819 CARBON STEEL 19# EUDAMED
I1 0812 CARBON STEEL 12# EUDAMED
SS #22 EUDAMED
I1 0820 CARBON STEEL 20# EUDAMED
I1 0811 CARBON STEEL 11PY# EUDAMED
SS #11 EUDAMED
I1 0821 CARBON STEEL 21# EUDAMED
SS #18 EUDAMED
SS #23 EUDAMED
SS #19 EUDAMED
SS #24 EUDAMED
I1 0818 CARBON STEEL 18# EUDAMED
SS #21 EUDAMED
SS #12 EUDAMED
"Asurity SS 10# I19910" EUDAMED

Identifiers

Primary DI / UDI-DI
16945630134255 EUDAMED
16945630134231 EUDAMED
16945630135092 EUDAMED
16945630134200 EUDAMED
16945630134170 EUDAMED
16945630135146 EUDAMED
16945630134217 EUDAMED
16945630134163 EUDAMED
16945630135078 EUDAMED
16945630134224 EUDAMED
16945630135108 EUDAMED
16945630135153 EUDAMED
16945630135115 EUDAMED
16945630135160 EUDAMED
16945630134194 EUDAMED
16945630135139 EUDAMED
16945630135085 EUDAMED
16945630135184 EUDAMED
Basic UDI-DI
6945630110BA EUDAMED
6945630107BM EUDAMED
6945630103BD EUDAMED
Unit of Use DI
06945630134258 EUDAMED
06945630134234 EUDAMED
06945630135095 EUDAMED
06945630134203 EUDAMED
06945630134173 EUDAMED
06945630135149 EUDAMED
06945630134210 EUDAMED
06945630134166 EUDAMED
06945630135071 EUDAMED
06945630134227 EUDAMED
06945630135101 EUDAMED
06945630135156 EUDAMED
06945630135118 EUDAMED
06945630135163 EUDAMED
06945630134197 EUDAMED
06945630135132 EUDAMED
06945630135088 EUDAMED
06945630135187 EUDAMED
EMDN Code
V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED
Austria EUDAMED
Belgium 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

mediware 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

Manufacturer
Sterilance Medical (Suzhou) Inc.
EUDAMED SRN
CN-MF-000002860
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (18)

  • EUDAMED 40ef85ac-c68e-4f76-b897-fc104a561fbb 61 fields · synced Sep 18, 2026
  • EUDAMED 9be09345-6fcb-4984-8be8-08c4a58bf53f 61 fields · synced May 16, 2026
  • EUDAMED 56a01b98-2b94-4164-adcc-84fe0f19459c 61 fields · synced May 16, 2026
  • EUDAMED 6a75fe7c-5bbb-4490-a475-1be5aca12135 61 fields · synced May 17, 2026
  • EUDAMED 27e35802-2a21-4834-8b53-7d8e8a78a484 61 fields · synced May 17, 2026
  • EUDAMED 86f402e3-4980-4144-82ae-7e7e35b75128 61 fields · synced May 17, 2026
  • EUDAMED 551f36c8-d2b5-42c5-80dd-f933c82ed32d 61 fields · synced May 17, 2026
  • EUDAMED 78bee8f1-821d-45a8-a6cf-b525fe5c811e 61 fields · synced May 18, 2026
  • EUDAMED 27598c19-a4d7-49b2-8ed5-76f4ef44fd39 61 fields · synced May 18, 2026
  • EUDAMED 27f7c2dc-1d4b-4914-93eb-930b153106af 61 fields · synced May 18, 2026
  • EUDAMED ce6e2c43-db6b-4276-a983-bdbb3d8922f0 61 fields · synced May 18, 2026
  • EUDAMED bb684cec-c6a4-46ea-8ca2-8ea8366805c4 61 fields · synced May 18, 2026
  • EUDAMED 238baf0d-84d6-4308-9090-6f54a7fceae0 61 fields · synced May 18, 2026
  • EUDAMED d9993719-1538-465c-8f02-9d6aa37c071c 61 fields · synced May 18, 2026
  • EUDAMED 61f06ce3-24da-4761-be43-0d676bd26b88 61 fields · synced May 18, 2026
  • EUDAMED f12c4569-7981-43b0-9ce4-9f98b93cfa3b 61 fields · synced May 18, 2026
  • EUDAMED de8e0aa5-97d7-4eed-8c30-06e51834cb56 61 fields · synced May 19, 2026
  • EUDAMED 8414074d-4c79-4fcd-aa25-13a615d1695d 61 fields · synced Jul 12, 2026