Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001415205

FEI Number

3001415205

Entity Name

BAITELLA AG

City/State/Country

ZURICH, CH

Establishment Address

THURGAUERSTRASSE 70, ZURICH CH-8050, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BAITELLA AG (Owner Number: 9094344)

Owner / Operator Contact Address

Thurgauerstrasse 70, --, Zurich, CH-ZH 8050, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2006-12-07
OCV	Endoscope Holder	Gastroenterology, Urology	Class 2	876.1500	2022-11-09
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2006-11-06
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-12-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-09-25
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2016-04-27

Official Correspondent

Juan Rubiano

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

BAITELLA AG

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-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

Similar Registrations

Registration Number	Establishment Name	Location
3027221819	MAGNAMED MEDICAL TECHNOLOGY	Fort Lauderdale, FL, US
3011971979	HAMILTON CENTRAL EUROPE	Giarmata Timis, RO
3014766741	Hamilton Medical AG	Domat / Ems Graubunden, CH
3015277818	HANGZHOU WEIZE IMP & EXP CO., LTD	Hangzhou Zhejiang, CN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001415205. Last updated year: 2026. Please use registration number 3001415205 when referencing this establishment in official correspondence.