FDA Registration
Active
🇩🇪 Germany
BERCHTOLD GMBH & CO. KG
Reg #: 8010153
·
FEI: 3006125657
·
Expires 2026
Products
7
Proprietary Names
83
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- BERCHTOLD GMBH & CO. KG
- Registration Number
- 8010153
- FEI Number
- 3006125657
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LUDWIGSTALER STR. 25
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
US Agent
- Business Name
- STRYKER ENDOSCOPY
- Contact Name
- April Malmborg
- Address
- 5900 OPTICAL CT., --
- City
- San Jose
- State
- CA
- ZIP
- 95138
- Country
- US
- [email protected]
- Phone
- 408 4093115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2014-12-18 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2016-04-07 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2006-01-18 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2014-12-18 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2010-06-08 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2014-12-18 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2016-02-09 |
Proprietary Names
Chromophare Surgical Light System
ACCEND Spring Arm, Classic, stop 12-21kg
ACCEND DROP TUBE HARDWARE KIT
ACCEND Suspension, L/FP, 1300/1200mm
ACCEND Lighthead Electronics Repair
ACCEND Ceiling Cover Hardware
ACCEND Drop Tube, 350mm
ACCEND Rotating Soffit Assembly
ACCEND Suspension, L/L, 1300/1200mm
ACCEND Drop Tube, 150 mm, M12
ACCEND Suspension Covers/Caps
ACCEND Drop Tube, 400 mm, M12
ACCEND Ceiling Cover
ACCEND SPRING ARM PACKAGING KIT
ACCEND Light Classic, 1050mm
ACCEND L/FP Classic, 1050/925mm
ACCEND Spring Arm Hardware
ACCEND Drop Tube, 150mm
ACCEND FP/L/L Flat, 1400/1300/1200mm
ACCEND Conduit Termination Plate
ACCEND L/FP Flat, 1300/1200mm
ACCEND Suspension, L/L, 1050/925mm
ACCEND Suspension, L/FP, 1050/925mm
ACCEND Flat Panel Hardware
ACCEND Suspension, FP/L/L, 1200/1050/925mm
ACCEND LIGHT HEAD PACKAGING KIT
ACCEND Suspension, Light, 1050mm
ACCEND FP/L/L Classic, 1200/1050/925mm
ACCEND Spring Arm, Flat, no stop 12-21kg
ACCEND Flat Panel Covers/Caps
ACCEND L/FP Flat, 1050/925mm
ACCEND Handle Adapter, Devon SlipOn
ACCEND Handle Adapter, Sterilizable
ACCEND Spring Arm Covers/Caps
ACCEND Flat Panel Mount
ACCEND Lighthead with Classic Cardanic
ACCEND Power Supply
ACCEND Spring Arm, Classic, no stop 12-21kg
ACCEND L/L Flat, 1300/1200mm
ACCEND Cardanic Control Repair
ACCEND Handle Cover, Sterilizable
ACCEND Cardanic Caps
ACCEND Drop Tube, 250 mm, M12
ACCEND Suspension Hardware
ACCEND LONG SUSPENSION PACKAGING KIT
ACCEND Suspension, FP/L/L, 1400/1300/1200mm
ACCEND Lighthead with Flat Cardanic
ACCEND Handle Adapter, Devon ScrewOn
ACCEND Drop Tube, 400mm
ACCEND SUSPENSION PACKAGING KIT
ACCEND L/L Classic, 1050/925mm
ACCEND Light Flat, 1050mm
Surgical Table and Accessory Pads
Visum 300 Exam Light
Visum XBlade LED Exam Light
CHROMOPHARE Examination Light
FD 6103 Sirca/ 32 FP
CE 3863075 Sirca Ceiling, Double Arm
CG 3913275 Sirca Wall, Double, Hardware
CF 3893075 Sirca Mobile US
FD 6203 Sirca/ UDM
CE 3853075 Sirca Ceiling, Single Arm
CG 3913175 Sirca Wall Double Outlet Plug
FS 6000 Sirca TC Double Arm
OPERON Accessories
K-TEK CURVE SPINE FRAME
K-TEK CLAMSHELL ARMBOARD PAD 3"
K-TEK LATERAL POSITIONER, ROUND
K-TEK SWIVEL ARMBOARD, SMALL
K-TEK CURVE CRANK HANDLE
K-TEK LATERAL POSITIONER, RECTANGLE
K-TEK SWIVEL ARMBOARD, LARGE
K-TEK COMFORT STANDARD ARMBOARD PAD, 2 3/8
K-TEK ARMBOARD, US
Strykecam 2 In-Light Camera
Strykecam HD In-Light Camera
CHROMOVISION HD Cameras
Strykecam HD for F-Gen
Strykecam for F-Gen
Strykecam for Visum LED
P59109 StrykeCam 4K, In-Light Camera
OPERON Surgical Tables, OPERON, X-Ray Cassette Tray, Inside Rail Clamp, Imaging Extension Filler Plate and Pad
Chromophore mobile
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198