FDA Registration
Active
🇩🇪 Germany
BGS BETA-GAMMA-SERVICE GMBH & CO KG
Reg #: 3009732568
·
FEI: 3009732568
·
Expires 2026
Products
82
Proprietary Names
9
Establishment Types
1
Classifications
82
Registration Details
- Registration Name
- BGS BETA-GAMMA-SERVICE GMBH & CO KG
- Registration Number
- 3009732568
- FEI Number
- 3009732568
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Fritz-Kotz-Strasse 16
- City
- Wiehl North Rhine-Westphalia
- Country
- DE
Owner / Operator
- Firm Name
- BGS Beta-Gamma-Service GmbH & Co KG
- Operator Number
- 10043097
- Address
- Fritz-Kotz-Strasse 16
- City
- Wiehl
- State
- North Rhine-Westphalia
- Postal Code
- 51674
- Country
- DE
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-11-16 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-12-10 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-12-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-12-21 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-04-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-11-02 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2020-12-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2020-12-07 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-12-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-12-07 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-12-12 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-12-12 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-12-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-12-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2014-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2014-12-13 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-15 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2018-06-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-01-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2020-01-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2020-01-19 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-12-29 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2015-10-23 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2015-10-30 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2015-08-12 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2015-08-12 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2018-12-28 |
| System, Therapeutic, X-Ray | JAD | Class 2 | Radiology | No | 2026-01-16 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2019-12-10 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-24 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2024-12-10 |
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2016-10-18 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-04-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-04-14 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2020-12-07 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2019-12-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-12-10 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2023-02-01 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2013-12-04 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-11-16 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2015-11-16 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-01-24 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2013-01-31 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2017-12-08 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-12-04 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2013-01-24 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2015-08-12 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2013-01-31 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2013-01-28 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2013-01-31 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2020-12-07 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-01-24 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-12-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2021-12-29 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2013-01-31 |
| Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented | HTG | Class 2 | Orthopedic | No | 2015-11-02 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2013-01-31 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2015-08-12 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2016-10-18 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2023-12-19 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-12-17 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2015-08-12 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2016-10-18 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2013-01-31 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-12-20 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2016-10-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2015-11-02 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2013-01-31 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2015-08-12 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2024-12-12 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2019-12-10 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2020-12-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-24 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-12-10 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-12-04 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-12-10 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2015-08-12 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2016-10-18 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2016-10-18 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2013-01-24 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2013-01-31 |
| Blood/Plasma Collection Device For Dna Testing | PJE | Class 2 | Clinical Chemistry | No | 2016-10-18 |
Proprietary Names
Actinia® hip stems
CliniMACS Prodigy Tubing Set 100 CE
15-2519/29
107-220/63
MUTARS® femoral stem cemented
implaFit® Hip Stem
BethaLoc® stem cementless HA
S-Monovette ACDA
71144
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)