FDA Registration
Active
🇩🇪 Germany
MEDINEEDLE - RESCUE GROUP RETTUNGSDIENST
Reg #: 3021194552
·
FEI: 3021194552
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- MEDINEEDLE - RESCUE GROUP RETTUNGSDIENST
- Registration Number
- 3021194552
- FEI Number
- 3021194552
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bruckenstrabe 10
- City
- Wolpertshausen Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K140560
Owner / Operator
- Firm Name
- Medineedle - Rescue Group Rettungsdienst
- Operator Number
- 10057331
- Address
- Bruckenstrabe 10
- City
- Wolpertshausen
- State
- Bavaria
- Postal Code
- 74549
- Country
- DE
- Correspondent
- Marco Schelhorn
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park W Apt 4d
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2018-03-22 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2018-03-22 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2018-03-22 |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | Class 2 | General, Plastic Surgery | No | 2018-03-22 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2018-03-22 |
Proprietary Names
The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reload
Securestrap 5mm absorbable strap fixation device
Ligaclip Endoscopic Rotating Multiple Clip Applier
Bard Ventralex Hernia Patch
Tri-Staple 2 Reinforced Reload
Ligamax 5 clip applier
HARMONIC ACE Shears with advanced hemostasis
ABSORBATACK Absorbable Fixation Device
Establishment Types
Export Device to the United States But Perform No Other Operation on Device