FDA Registration
Active
🇧🇬 Bulgaria
SAINT JONES MANAGEMENT LP EOOD
Reg #: 3016904853
·
FEI: 3016904853
·
Expires 2026
Products
67
Proprietary Names
1
Establishment Types
3
Classifications
67
Registration Details
- Registration Name
- SAINT JONES MANAGEMENT LP EOOD
- Registration Number
- 3016904853
- FEI Number
- 3016904853
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Stefan Kirov 42
- City
- Sofia Sofia-Grad
- Country
- BG
Regulatory Submissions
- 510(k) Number
- K201075
Owner / Operator
- Firm Name
- Saint Jones Management LP EOOD
- Operator Number
- 10074449
- Address
- Stefan Kirov 42
- City
- Sofia
- State
- Sofia-Grad
- Postal Code
- 1111
- Country
- BG
- Correspondent
- Daniel Rizov
US Agent
- Business Name
- SOUTHEASTERN INTERNATIONAL GROUP LLC
- Contact Name
- IGNACIO AGOTE
- Address
- 2820 sw 42nd street
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33312
- Country
- US
- [email protected]
- Phone
- 954 5233855
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-06-06 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-06-06 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2024-12-23 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2024-05-22 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-09-06 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2025-09-08 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-05-22 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2025-02-21 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2024-05-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-05-22 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2025-11-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Absorber, Carbon-Dioxide | BSF | Class 1 | Anesthesiology | No | 2022-02-17 |
| Reprocessed Blood Pressure Cuff | NPP | Class 2 | Cardiovascular | No | 2023-11-07 |
| Light, Headband, Surgical | FSR | Class 2 | Ophthalmic | No | 2025-08-12 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2024-02-22 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2025-11-24 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-11-07 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2023-11-07 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-05-20 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2024-12-19 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2020-08-31 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2025-11-25 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-05-22 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-12-02 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2026-01-15 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-05-06 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-11-07 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2025-05-06 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2020-05-26 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2024-08-09 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2025-05-20 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-11-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2025-05-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-05-06 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2024-05-22 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2025-05-06 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-05-06 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2024-08-13 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2025-11-24 |
| Absorbent, Carbon-Dioxide | CBL | Class 1 | Anesthesiology | No | 2022-02-17 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2020-05-28 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2025-05-06 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2024-09-20 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2024-05-22 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2024-02-22 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2020-05-24 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2020-11-11 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2023-06-06 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2025-05-06 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2025-02-19 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2023-11-07 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-08-08 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2024-08-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-02-11 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2024-08-08 |
Proprietary Names
SAINT JONES
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device