BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    AESCULAP CHIFA SP. Z O.O.

    Reg #: 9680260 · FEI: 3002315844 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    57
    Establishment Types
    3
    Classifications
    38

    Registration Details

    Registration Name
    AESCULAP CHIFA SP. Z O.O.
    Registration Number
    9680260
    FEI Number
    3002315844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    UL. TYSIACLECIA 14
    City
    NOWY TOMYSL Wielkopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K012225

    Owner / Operator

    Firm Name
    AESCULAP CHIFA SP. Z O. O.
    Operator Number
    9007699
    Address
    UL. TYSIACLECIA 14, --
    City
    NOWY TOMYSL
    State
    Wielkopolskie
    Postal Code
    64-300
    Country
    PL
    Correspondent
    TOMASZ - KLUJ

    US Agent

    Business Name
    Aesculap, Inc.
    Contact Name
    Kamaal Anas
    Address
    3773 Corporate Parkway
    City
    Center Valley
    State
    PA
    ZIP
    18034
    Country
    US
    Email
    [email protected]
    Phone
    610 9849071 ext. 5071

    Products

    Device Name Product Code
    Dilator, Cervical, Fixed Size HDQ
    Retractor GAD
    Gouge, Surgical, General & Plastic Surgery GDH
    Instrument, Cutting, Orthopedic HTZ
    Mallet, Surgical, General & Plastic Surgery GFJ
    Retractor, Self-Retaining FFO
    Forceps, General & Plastic Surgery GEN
    Pliers, Operative EJY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Forceps, Tooth Extractor, Surgical EMG
    Carrier, Ligature GEJ
    Elevator, Surgical, Dental EMJ
    Cutter, Surgical FZT
    File, Surgical, General & Plastic Surgery GEO
    Rongeur, Manual HAE
    Forceps, Rongeur, Surgical EMH
    Instrument, Microsurgical GZX
    Forceps, Ophthalmic HNR
    Scissors, General, Surgical LRW
    Handle, Scalpel GDZ
    Catheter, Flow Directed DYG
    Elevator, Surgical, General & Plastic Surgery GEG
    Instrument, Cast Application/Removal, Manual LGG
    Scissors, Collar And Crown EIR
    Holder, Needle, Gastroenterologic FHQ
    Forceps, Rubber Dam Clamp EJG
    Scissors, Surgical Tissue, Dental EGN
    Curette, Surgical, General Use FZS
    Plier, Orthodontic JEX
    Pliers, Surgical HTC
    Instrument, Ligature Tucking, Orthodontic ECP
    Scissors, Medical, Disposable JOK
    Speculum, Vaginal, Metal HDF
    Clamp, Surgical, General & Plastic Surgery GDJ
    Instrument, Manual, Surgical, General Use MDM
    Cutter, Wire HXZ
    Mallet HXL
    Tray, Surgical, Instrument FSM

    Proprietary Names

    RETRACTOR VARIOUS TYPES OF GOUGES LAMBOTTE) (ALEXANDER GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, CUTTING, ORTHOPEDIC MALLET, SURGICAL, GENERAL & PLASTIC SURGERY VARIOUS TYPES OF RETRACTORS FORCEPS, GENERAL & PLASTIC SURGERY FORCEPS MAGNUM MEDICAL INC. Aesculap VARIOUS TYPES OF ENGLIS FORCEPS, TOOTH EXTRACTOR, SURGICAL LIGATURE VARIOUS MODELS SURGICAL DENTAL ELEVATORS ELEVATOR, SURGICAL, DENTAL NAIL) CUTTERS VARIOUS TYPES OF SURGICAL (WIRE MULTIPLE SURGICAL FILES FILE, SURGICAL, GENERAL & PLASTIC SURGERY FORCEPS, RONGEUR, SURGICAL MULTIPLE MICROSURGICAL INSTRUMENTS INSTRUMENT, MICROSURGICAL MC PHERSON FORCEPS, OPHTHALMIC SCISSORS, GENERAL, SURGICAL VARIOUS TYPES OF SURG ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL CROWN SCISSORS SCISSORS, COLLAR AND CROWN HOLDER, NEEDLE, GASTROENTEROLOGIC FORCEPS, RUBBER DAM CLAMP BREWER AIMSWORTH VARIOUS TYPES AND SIZES OF SCISSORS SCISSORS, SURGICAL TISSUE, DENTAL PLIER, ORTHODONTIC PLIERS, SURGICAL BAND HOLDERS HOW LIGATURE PLIERS FURRER PLIERS MEDICAL DISPOSABLE SCISSORS GENTOFT FENO SPECULUM, VAGINAL, METAL TOWEL CLAMPS SIZES BACKHAUS , VARIOUS TYPES CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, MANUAL, SURGICAL, GENERAL USE CUTTER, WIRE MALLET

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device