EUDAMED update: Feb 13, 2024

Ormco Corporation

US-MF-000038085

Active6,487 devices

Address: S Kraemer Blvd, 200 92821 Brea
Role: Manufacturer
Date of registration: Oct 10, 2023
Country: United States

Ormco Corporation is a medical device manufacturer registered in EUDAMED. The company has 6,487 devices on the EU market across 32 countries. Headquartered in Brea, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Ormco Corporation

: US-MF-000038085
Role: Manufacturer
Country: United States
Organization name: Ormco Corporation
EU VAT number: 33-0463207
EORI: n/a
Trade register: 3015272949
Date of registration: Oct 10, 2023

Contact details for Ormco Corporation

Email: procoro.herrera@envistaco.com
Address: 200, S KRAEMER BLVD 92821 BREA UNITED STATES

Competent authority

Name: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico

Phone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

Officers and regulatory representatives of Ormco Corporation

HERRERA Procoro
Hidden

Connected operators

Importers

2 EU importers place this manufacturer's devices

Data export

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
1/4" PADS FOR ADHESIVE REMOVING PLIERS	1/4" PADS FOR ADHESIVE REMOVING PLIERS	`866-2059`	`00889989082715`	1	On the market
1/4" PADS FOR BAND REMOVING PLIERS	1/4" PADS FOR BAND REMOVING PLIERS	`866-2058`	`00889989082708`	1	On the market
15 DEGREE MICRO MINI LIGATURE CUTTER	15 DEGREE MICRO MINI LIGATURE CUTTER	`800-1000`	`00889989075656`	1	On the market
28 CUNITI STRAIGHTWIRE 8 1/2 LG - .013 DIA PK10	28 CUNITI STRAIGHTWIRE 8 1/2 LG - .013 DIA PK10	`266-1360`	`00889989033762`	1	On the market
3/16" PADS FOR BAND REMOVING PLIERS	3/16" PADS FOR BAND REMOVING PLIERS	`866-2061`	`00889989082739`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-16 DIA PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-16 DIA PK100	`266-2001`	`00889989085976`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-16X22 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-16X22 PK100	`266-2100`	`00889989085983`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-17X17 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-17X17 PK100	`266-2104`	`00889989086027`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-17X25 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-17X25 PK100	`266-2101`	`00889989085990`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-18X25 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-18X25 PK100	`266-2103`	`00889989086010`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-19X25 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-19X25 PK100	`266-2102`	`00889989086003`	1	On the market
5-5 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ	5-5 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ	`740-1408`	`00889989080490`	1	On the market
5-5 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ	5-5 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ	`740-1407`	`00889989080483`	1	On the market
5DEG SHEATH-L 036 NO HK EA	5DEG SHEATH-L 036 NO HK EA	`088-4009`	`00889989014006`	1	On the market
5DEG SHEATH-L 036 W/BHK EA	5DEG SHEATH-L 036 W/BHK EA	`088-4007`	`00889989013986`	1	On the market
5DEG SHEATH-R 036 NO HK EA	5DEG SHEATH-R 036 NO HK EA	`088-4008`	`00889989013993`	1	On the market
5DEG SHEATH-R 036 W/BHK EA	5DEG SHEATH-R 036 W/BHK EA	`088-4006`	`00889989013979`	1	On the market
7-7 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	7-7 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	`740-1409`	`00889989080506`	1	On the market
7-7 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	7-7 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	`740-1406`	`00889989080476`	1	On the market
A.D. PROTRACTION FACEMASK BLUE	A.D. PROTRACTION FACEMASK BLUE	`716-0001`	`00889989059908`	1	On the market
A.D. PROTRACTION FACEMASK LAVENDER	A.D. PROTRACTION FACEMASK LAVENDER	`716-0002`	`00889989059915`	1	On the market
ACCENT B/T 5DBL LFM -27TX18X18 LT	ACCENT B/T 5DBL LFM -27TX18X18 LT	`521-0232`	`00889989054316`	1	On the market
ACCENT B/T 5DBL LFM -27TX18X18 RT	ACCENT B/T 5DBL LFM -27TX18X18 RT	`520-0232`	`00889989054248`	1	On the market
ACCENT B/T 5DBL LFM -27TX22X21 LT	ACCENT B/T 5DBL LFM -27TX22X21 LT	`521-0231`	`00889989054309`	1	On the market
ACCENT B/T 5DBL LFM -27TX22X21 RT	ACCENT B/T 5DBL LFM -27TX22X21 RT	`520-0231`	`00889989054231`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
1/4" PADS FOR ADHESIVE REMOVING PLIERS	1/4" PADS FOR ADHESIVE REMOVING PLIERS	`866-2059`	`00889989082715`	1	On the market
1/4" PADS FOR BAND REMOVING PLIERS	1/4" PADS FOR BAND REMOVING PLIERS	`866-2058`	`00889989082708`	1	On the market
15 DEGREE MICRO MINI LIGATURE CUTTER	15 DEGREE MICRO MINI LIGATURE CUTTER	`800-1000`	`00889989075656`	1	On the market
28 CUNITI STRAIGHTWIRE 8 1/2 LG - .013 DIA PK10	28 CUNITI STRAIGHTWIRE 8 1/2 LG - .013 DIA PK10	`266-1360`	`00889989033762`	1	On the market
3/16" PADS FOR BAND REMOVING PLIERS	3/16" PADS FOR BAND REMOVING PLIERS	`866-2061`	`00889989082739`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-16 DIA PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-16 DIA PK100	`266-2001`	`00889989085976`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-16X22 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-16X22 PK100	`266-2100`	`00889989085983`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-17X17 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-17X17 PK100	`266-2104`	`00889989086027`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-17X25 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-17X25 PK100	`266-2101`	`00889989085990`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-18X25 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-18X25 PK100	`266-2103`	`00889989086010`	1	On the market
35CUNITI STRAIGHTWIRE 8 1/2 LG-19X25 PK100	35CUNITI STRAIGHTWIRE 8 1/2 LG-19X25 PK100	`266-2102`	`00889989086003`	1	On the market
5-5 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ	5-5 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ	`740-1408`	`00889989080490`	1	On the market
5-5 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ	5-5 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ	`740-1407`	`00889989080483`	1	On the market
5DEG SHEATH-L 036 NO HK EA	5DEG SHEATH-L 036 NO HK EA	`088-4009`	`00889989014006`	1	On the market
5DEG SHEATH-L 036 W/BHK EA	5DEG SHEATH-L 036 W/BHK EA	`088-4007`	`00889989013986`	1	On the market
5DEG SHEATH-R 036 NO HK EA	5DEG SHEATH-R 036 NO HK EA	`088-4008`	`00889989013993`	1	On the market
5DEG SHEATH-R 036 W/BHK EA	5DEG SHEATH-R 036 W/BHK EA	`088-4006`	`00889989013979`	1	On the market
7-7 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	7-7 U/L DAMON CLEAR 2, DAMON CLEAR & DAMON Q SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	`740-1409`	`00889989080506`	1	On the market
7-7 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	7-7 U/L DAMON CLEAR 2, DAMON Q & DAMON CLEAR SINGLE PATIENT KIT: STD-TQ, SNAPLINK & TI TUBES	`740-1406`	`00889989080476`	1	On the market
A.D. PROTRACTION FACEMASK BLUE	A.D. PROTRACTION FACEMASK BLUE	`716-0001`	`00889989059908`	1	On the market
A.D. PROTRACTION FACEMASK LAVENDER	A.D. PROTRACTION FACEMASK LAVENDER	`716-0002`	`00889989059915`	1	On the market
ACCENT B/T 5DBL LFM -27TX18X18 LT	ACCENT B/T 5DBL LFM -27TX18X18 LT	`521-0232`	`00889989054316`	1	On the market
ACCENT B/T 5DBL LFM -27TX18X18 RT	ACCENT B/T 5DBL LFM -27TX18X18 RT	`520-0232`	`00889989054248`	1	On the market
ACCENT B/T 5DBL LFM -27TX22X21 LT	ACCENT B/T 5DBL LFM -27TX22X21 LT	`521-0231`	`00889989054309`	1	On the market
ACCENT B/T 5DBL LFM -27TX22X21 RT	ACCENT B/T 5DBL LFM -27TX22X21 RT	`520-0231`	`00889989054231`	1	On the market

Ormco Corporation

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Devices by risk class

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Device families (Basic UDI-DI) of Ormco Corporation