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First Blades

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref Standard SS 10#

by Sterilance Medical (Suzhou) Inc.

Identity

Trade Name
FIRST BLADES EUDAMED
FIRST BLADES DISPOSABLE SURGICAL BLADES FDA UDI
Generic Name
Manual scalpel blade, single-use FDA UDI
Device Name
Disposable Surgical Blades EUDAMED
Model / Reference
Standard SS 10# EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
16945630133616 EUDAMEDFDA UDI
Basic UDI-DI
6945630111BC EUDAMED
Unit of Use DI
06945630133619 EUDAMED
FDA Product Code
GES FDA UDI
EMDN Code
V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term
Manual scalpel blade, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

First Blades by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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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 (2)

  • EUDAMED 2e936bee-ba58-4300-972c-b380b6966e2e 61 fields · synced Jun 20, 2026
  • FDA UDI 2f8977f9-472c-4f9a-b07f-a269965582e6 32 fields · synced May 27, 2026