3d-Shaper

FDA UDIEUDAMED

Class II (US FDA UDI)

by 3d-Shaper Medical S.l.

Identity

Trade Name: 3D-SHAPER FDA UDI
Generic Name: Surgical simulation system FDA UDI
Model / Reference: 2.11 FDA UDI

Identifiers

Primary DI / UDI-DI: 08437021740028 FDA UDI
510(k) Number: K220822 FDA UDI
FDA Product Code: KGI FDA UDI
GMDN Term: Surgical simulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1170 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical simulation system

3d-Shaper by 3d-Shaper Medical S.l. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: 3d-Shaper Medical S.l.

Sources (2)

FDA UDI 5da366fb-d416-4341-a6bf-e8a749f653cc 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026