EmbedMed

FDA UDI

Class II (US FDA UDI)

by 3D Lifeprints UK , Ltd.

Identity

Trade Name: EmbedMed FDA UDI
Generic Name: Custom-made organ/bone anatomy model FDA UDI
Device Name: Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization FDA UDI
Model / Reference: OTHAMFEUS FDA UDI
Description: Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization FDA UDI

Identifiers

Primary DI / UDI-DI: 00860009815766 FDA UDI
FDA Product Code: PBF FDA UDI
LLZ FDA UDI
GMDN Term: Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Custom-made organ/bone anatomy model

EmbedMed by 3D Lifeprints UK , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: 3D Lifeprints UK , Ltd.

Sources (1)

FDA UDI 6ce85e08-9a72-470e-aa75-9e3c15c0e221 33 fields · synced May 30, 2026