Humeca blade for Zimmer® 8801-8821 dermatome, 10pcs

EUDAMED

Class IIa (EU MDR)

Ref 5.BLZM10

by Humeca B.V.

Identity

Device Name: Humeca blade for Zimmer® 8801-8821 dermatome, 10pcs EUDAMED
Model / Reference: 5.BLZM10 EUDAMED

Identifiers

Primary DI / UDI-DI: 08717903495445 EUDAMED
Basic UDI-DI: B-08717903495445 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: Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Manual scalpel blade, single-use

Humeca blade for Zimmer® 8801-8821 dermatome, 10pcs by Humeca B.V. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Manual scalpel blade, single-use.

Paramount — Paramount Surgimed Limited · Class IIa
Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
Swann-Morton — Swann-Morton Ltd · Class IIa
SHARD — APPLIED DENTAL, INC. · Class I
Sterile Stainless Blades — Southmedic Incorporated · Class I
Paramount — Paramount Surgimed Limited · Class IIa
Swann-Morton — Swann-Morton Ltd · Class IIa
SHARD — APPLIED DENTAL, INC. · Class I

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08717903495445	Class IIa	Active

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Manufacturer

Manufacturer: Humeca B.V.
EUDAMED SRN: NL-MF-000010933

Sources (1)

EUDAMED 8491463c-6dd3-4b52-8c10-a977d2ac137b 61 fields · synced Oct 6, 2026