← Back to catalogue

Agili-C

FDA UDI

Class III (US FDA UDI)

by Cartiheal (2009) Ltd

Identity

Trade Name
Agili-C FDA UDI
Generic Name
Osteochondral matrix implant FDA UDI
Device Name
5X Agili-C D7.5 Implant FDA UDI
Model / Reference
CHP0755 FDA UDI
Description
5X Agili-C D7.5 Implant FDA UDI

Identifiers

Primary DI / UDI-DI
07290019087182 FDA UDI
PMA Number
P210034 FDA UDI
FDA Product Code
QRU FDA UDI
GMDN Term
Osteochondral matrix implant FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Osteochondral matrix implant

Agili-C by Cartiheal (2009) Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteochondral matrix implant.

Cleared under the same submission

P210034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cartiheal (2009) Ltd

Sources (1)

  • FDA UDI 21b718e7-dab1-4417-b8c3-2b2c39e04d03 35 fields · synced Jun 6, 2026