Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016603289

FEI Number

3016603289

Entity Name

Apellis

City/State/Country

Waltham, MA, US

Establishment Address

100 5th Ave, Waltham, MA 02451, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Apellis (Owner Number: 10089225)

Owner / Operator Contact Address

100 5th Ave, 3rd floor, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Empaveli Injector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLF	On-Body Injector	General Hospital	Class 2	880.5860	2023-11-16
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2025-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Apellis

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0490-2025	Alcon Research LLC	2	a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

Similar Registrations

Registration Number	Establishment Name	Location
2032861	West Pharmaceutical Services Arizona, Inc.	Tempe, AZ, US
2032862	West Pharmaceutical Services AZ, Inc.	SCOTTSDALE, AZ, US
3012484616	ENABLE INJECTIONS	Cincinnati, OH, US
3027691164	LTS DEVICE TECHNOLOGIES	Netanya Central, IL
3008816891	A+ SECURE PACKAGING	La Vergne, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016603289. Last updated year: 2026. Please use registration number 3016603289 when referencing this establishment in official correspondence.