FDA Registration
Active
🇩🇪 Germany
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
Reg #: 3002858762
·
FEI: 3002858762
·
Expires 2026
Products
62
Proprietary Names
63
Establishment Types
3
Classifications
62
Registration Details
- Registration Name
- SPIGGLE & THEIS MEDIZINTECHNIK GMBH
- Registration Number
- 3002858762
- FEI Number
- 3002858762
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Burghof 14
- City
- OVERATH North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K223542
Owner / Operator
- Firm Name
- SPIGGLE & THEIS MEDIZINTECHNIK GMBH
- Operator Number
- 9050994
- Address
- Burghof 14, --
- City
- OVERATH
- State
- DE-NOTA
- Postal Code
- 51491
- Country
- DE
- Correspondent
- Claudia - Winterschladen
US Agent
- Business Name
- Bryan Medical Inc.
- Contact Name
- David Rattigan
- Address
- 6100 Wooster Pike
- City
- Cincinnati
- State
- OH
- ZIP
- 45227
- Country
- US
- [email protected]
- Phone
- 513 2721600
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 2017-05-05 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2018-04-12 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2018-04-16 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2017-05-09 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2025-09-10 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Forceps, Wire Closure, Ent, Non-Sterile | NNQ | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2002-04-30 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-02-27 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2025-09-11 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2025-05-30 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2025-09-12 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2025-09-11 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2016-07-27 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2023-09-05 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2018-04-05 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2025-09-17 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2018-04-12 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2018-03-12 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2018-03-12 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2016-08-19 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2009-05-25 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2018-02-20 |
| Dilator, Esophageal, Ent | KCF | Class 1 | Ear, Nose, Throat | No | 2025-12-11 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2017-05-05 |
| Spoon, Ear | JZE | Class 1 | Ear, Nose, Throat | No | 2025-09-01 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2017-05-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2020-12-18 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2009-05-25 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Spectacle Microscope, Low-Vision | HKC | Class 1 | Ophthalmic | No | 2018-02-19 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2018-02-19 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2018-04-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-02-19 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2018-02-19 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-05-20 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2017-05-09 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2018-02-19 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2025-05-23 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2012-04-17 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2024-09-12 |
| Support, Head, Surgical, Ent | EPW | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2017-09-18 |
| Weights, Eyelid, External | MML | Class 2 | Ophthalmic | No | 2010-07-23 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2018-02-19 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2025-12-11 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2018-02-19 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2017-05-09 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2018-02-19 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2018-02-19 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2018-02-19 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2018-04-12 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2021-02-15 |
Proprietary Names
Nasal splints
Depressor, Metal Tongue Surgical
Teeth Protector
Surgical Laryngoscope
Suction Tubes, ENT, Single Use
Block, Cutting, ENT, NON-STERILE
Forceps, Wire Closure, ENT, Non-Sterile
Epistaxis catheter
Drape, Robotic, sterile
Monitor Drape, sterile
Spatula
Trocar Spiggle & Theis
Mouth gag
Punch, ENT
Panetti Suction Instruments
TubaVent Balloon Dilatation System
Osteotome, Manual
Rasp
Knife, ENT
REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL , PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
Otoscope, large picture
Hook, microsurgical ear
Mallet
ENT Dilator SPIGGLE THEIS
PVA intranasal tampon
Volkmann sharp spoon
Scissors, Nasal
ENT, Forceps, Scissors, Punches, Hooks, Instruments
VoiceInject Injection Needle, Lipo Harvesting Cannula
Chisel, middle ear Spiggle Theis
Forceps for Laryngology, ENT
Ear Scissors
Spectacle, Magnifier
Pean, Kocher, Crile Artery forceps
Loop, wire SPIGGLE THEIS
Chisel Spiggle & Theis
Retractor, Helms, Preyer, Fisch, Wullstein, Wigand, Perkins etc.
Loupe, binocular
PVA Tampons Ear
ENT Bandages
Gauge, Measuring - Reference Instrument
Perforator, Fisch Footplate Perforator
Probe, ENT
Eicken Antrum Canula, Frazier Tube
Mentio, ear speculum disposable
Mirror, ENT
Nipper, Malleus
Source, Carrier, Fiberoptic Light
Handle, Handpiece for instruments Laryngology
Manual operating accessories, table, bowls, cups
Table and Attachments, Operating room
Lid-Chain (lid implant) acc. Berghaus/Schrom
Elevator, ENT
Curette
Snare, tonsil SPIGGLE THEIS
Light Surgical Headlight
System Screen Basket & Accessories
Tuning Fork, Noise Apparatus
Scalpel Blades, single sterile packed
Speculum, ENT
Bruening aural magnifier speculum set
Injection Needle, Reusable
Tympano Sizer
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility